66 Regulatory Affairs jobs in Australia

Join to apply for the Regulatory Affairs Lead role at Cepheid

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Join to apply for the Regulatory Affairs Lead role at Cepheid

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At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the Danaher Business System which makes everything possible.
The Regulatory Affairs (RA) Lead is responsible for regulatory strategy, submissions, license management, in-country testing, and audit support for regulated countries throughout the Asia/Asia Pacific (APAC) region. The Lead will serve as the subject matter expert on cross-functional projects to ensure key performance indicators are met. Provide guidance and training to associates to ensure skilled competencies of global Regulatory standards and requirements at Cepheid.
This position is part of Regulatory Affairs, Global Market Expansion and will be located in Australia. The role will report to the Senior Director, Regulatory Affairs.
In this role, you will have the opportunity to:

• Serve in the following: preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals.
• Mentor and coach team on complex regulatory business initiatives.
• Manage and translate strategy/plan into goals by building repeatable processes that help manage the team’s sustained delivery on performance metrics.
  

• Bachelor's degree with 8+ years of related work experience, OR Master's degree in field with 6+ years of related work experience, OR Doctoral degree in field with 3+ years of related work experience; AND at least 2 years supervising people.
• Experience leading regulatory submissions and interactions with regulatory authorities (e.g. TGA) with an in-depth knowledge of global regulatory requirements, standards, and guidelines (including ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations).
• Strong written and communication skills; comfortable working in a dynamic multi-functional matrix organization.
  

• Experience in supporting Quality Assurance activities.
• Technical experience within the in vitro diagnostic or medical device industries.
  

• Seniority level Not Applicable

• Employment type Full-time

• Job function Legal
• Industries Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Cepheid by 2x

Sydney, New South Wales, Australia 3 weeks ago

Millers Point, New South Wales, Australia 2 weeks ago

Warriewood, New South Wales, Australia 1 week ago

Sydney, New South Wales, Australia A$100,000.00-A$140,000.00 4 weeks ago

Sydney, New South Wales, Australia 1 month ago

Sydney, New South Wales, Australia 1 day ago

Macquarie Park, New South Wales, Australia 1 month ago

Sydney, New South Wales, Australia 1 month ago

Sydney, New South Wales, Australia 3 days ago

Sydney, New South Wales, Australia 1 month ago

Sydney, New South Wales, Australia 1 day ago

Sydney, New South Wales, Australia 3 days ago

Sydney, New South Wales, Australia 1 day ago

St Leonards, New South Wales, Australia 1 week ago

Sydney, New South Wales, Australia 4 days ago

Sydney, New South Wales, Australia 2 days ago

Sydney, New South Wales, Australia 2 days ago

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 2 weeks ago

Parramatta, New South Wales, Australia 1 week ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

1 month ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from MedReleaf Australia

Job location: Anywhere in Australia (Remote)

Hours: 38 hours per week, Monday – Friday

About us:

We’re MedReleaf Australia – a leading provider of alternative medicine in Australia, dedicated to improving the lives of others. We’re paving the way for the industry with a talented team of professionals who help introduce holistic healthcare solutions across Australia. Together, we’ve defined what we call the MedReleaf Way - a secret recipe for success that allows us to be a trusted provider, educator, and leader in the industry for our community - and this is what makes us a special place to work.

We’re in an exciting period of growth and are on a mission to expand our team across Australia with a range of dynamic opportunities. We’re now part of a global network of Aurora Cannabis, a world-leading integrated medical cannabis company with a strong reputation for setting the global standard in alternative medicine care. With a strong presence in markets including Canada, Europe, Australia, and New Zealand, Aurora brings invaluable expertise that will support our growth and continue to enable us to deliver exceptional patient care within our community. If this is not the role for you, check out our Global Aurora Careers Page to find the perfect opportunity.

About you:

Plant your roots with us as our next Director Regulatory Affairs where you will play critical leadership role overseeing regulatory compliance, public policy development and other strategic initiatives critical for MedReleaf Australia’s operations in Australia and New Zealand. You will be responsible for developing and executing regulatory strategies to further our regulatory and commercial interests, ensuring compliance with applicable laws and industry standards, and serving as the primary interlocutor with regulatory authorities and public policy leads, including the Ministry of Health (NZ), New Zealand Medicinal Cannabis Council (NZ), Therapeutic Goods Administration (TGA), the Office of Drug Control (ODC) and Australian Health Practitioner Regulation Agency (AHPRA).

In this role you will ensure the integrity of our products and services while driving alignment with regulatory frameworks and influencing policy to support business objectives. Critical to this role will be strengthening our position as a trusted leader in the medicinal cannabis industry and ensures sustainable growth and compliant practices across the ANZ market. Sound exciting? Here is a little more…

As the Director Regulatory Affairs you will oversee…

Regulatory Leadership and Strategy

• Develop and oversee the execution of comprehensive regulatory strategies to support product development, registration, licensing, and approval processes across ANZ.
• Ensure ongoing compliance with local, national, and international regulatory requirements.
• Act as a strategic advisor on regulatory matters, collaborating with senior leadership to align regulatory priorities with business goals.
• Monitor and evaluate regulatory trends and provide forward-looking guidance to anticipate and address potential challenges.

Public Policy Development

• Working within the Centre of Excellence, collaborate with colleagues to support the development and implementation of government relations strategies to influence government policies, regulations, and legislation supporting the growth of the medicinal cannabis industry in the ANZ market.
• Leverage opportunities to support MRA/Aurora’s participation in local/regional industry associations or related special events that are focused on broadening relationships with government decision-makers, facilitating access to medical cannabis for patients, and other objectives that are in alignment with Aurora’s corporate outcomes in ANZ.
• Collaborate with internal teams, including Legal, Regulatory, and Quality Assurance, to ensure government relations efforts are aligned with organizational objectives.

Team Oversight and Cross-Functional Collaboration

• Lead, mentor, and manage the Regulatory Affairs and Compliance team across ANZ to ensure high performance and professional development.
• Collaborate with R&D, Quality Assurance, Legal, and other teams to integrate regulatory considerations into product development, manufacturing, and marketing activities.
• Provide training to internal stakeholders on regulatory changes and ensure organizational readiness for compliance.

Regulatory Operations and Agency Engagement

• Serve as the primary interlocutor with regulatory authorities, including but not limited to Therapeutic Goods Administration (TGA), the Office of Drug Control (ODC), Australian Health Practitioner Regulation Agency (AHPRA), Ministry of Health (NZ) and New Zealand Medicinal Cannabis Council (NZ), managing all submissions, queries, and inspections.
• Oversee the preparation and submission of regulatory documentation, ensuring accuracy and adherence to timelines.
• Build and maintain strong relationships with regulatory agencies, ensuring effective communication and advocacy for the organization’s interests.

Compliance and Risk Management

• Oversee the implementation and maintenance of the Quality Management System (QMS), ensuring adherence to regulatory and quality standards.
• Manage all relevant licenses, permits, and certifications, ensuring timely renewals and compliance with applicable regulations with applicable team members.
• Conduct internal audits and risk assessments, implementing corrective and preventive actions to address quality or compliance gaps.
• Ensure the timely resolution of complaints, adverse events, and quality issues in accordance with regulatory guidelines.

Operational Excellence and Continuous Improvement

• Lead initiatives to optimize the Business’ SAS program, Portal rollout, and CSO network expansion, ensuring seamless execution and compliance.
• Oversee the review and approval of product labelling, barcodes, and packaging materials to meet regulatory requirements.
• Collaborate with external partners, vendors, and industry stakeholders to ensure compliance and support regulatory reform efforts.

You’ll be set up for success if you have…

• Bachelor’s degree in Law, Regulatory Affairs, or a related field.
• 8 + years of progressive experience in regulatory affairs, compliance, and quality management, with at least 2–3 years within the pharmaceutical or medicinal cannabis industry preferred.
• Proven success in preparing and submitting regulatory documents for product approvals and managing regulatory inspections.
• Demonstrated experience working with regulatory authorities, such as but not limited to the TGA and ODC, Ministry of Health (NZ) and New Zealand Medicinal Cannabis Council (NZ), with a thorough understanding of regulatory requirements in Australia and New Zealand.
• Experience working in a global public and matrix environment, ideally in medical cannabis.
• Experience navigating complex, matrix, resource-constrained environments, managing ambiguity, and adapting to continuous change while maintaining a focus on organizational goals.

We can’t wait to meet you if you have…

• Exceptional regulatory affairs expertise with in-depth knowledge of regulatory processes, including product registration, submissions, and compliance, with a strong understanding of pharmaceutical regulations, guidelines, and quality standards, including Good Manufacturing Practice (GMP) principles. Possesses a track record of problem resolution.
• Strong communication skills for effective interaction with regulatory agencies and internal stakeholders.
• Excellent project management skills to ensure timely and accurate submission of regulatory documents.
• Strong analytical skills for interpreting and applying regulatory requirements to business processes.
• Strong judgment to evaluate options and implement effective strategies to address compliance, regulatory, and government relations needs.
• Understanding of corporate strategy, market dynamics, and how regulatory and government relations influence business objectives with experience working in matrix global environments and influencing decision-making.
• Proven ability to lead, mentor, and manage cross-functional teams, fostering collaboration and high performance.
• Competence in managing regulatory and reputational risks, ensuring effective responses to compliance or policy-related challenges.
• Demonstrated ability to lead with courage and integrity, speak truth to power, and foster collaboration to drive success, while embodying our values of Winning Together, Courage, Accountability, and Compassion in all actions
• Possesses the ability to adapt quickly , while maintaining focus and a high degree of accuracy maneuvering complex data in an environment of everchanging deadlines, priorities, and requirements

This role requires travel, schedule flexibility, and a satisfactory Police and Reference Check.

With us, you will find a place where you belong and love where you work with a whole crop of benefits like the following:

• Competitive Compensation: Enjoy a base salary, super, annual bonus (when applicable) and more!
• Professional Development: Unlock robust growth opportunities with access to conferences, workshops, webinars, a study support program for tuition, and career development
• Work-Life Balance: Prioritize your well-being with our flexible work structure, offering remote work options, annual and personal leave options
• Vibrant Culture: Join a dynamic team with exciting events like sales celebrations, holiday parties, volunteer initiatives, and product launches that make every day memorable

Next steps:

Submit your resume through LinkedIn by clicking “Apply Now”.

• Seniority level Director

• Employment type Full-time

• Job function Legal, General Business, and Management
• Industries Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at MedReleaf Australia by 2x

Get notified about new Director of Regulatory Affairs jobs in Australia .

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

We have an exciting opportunity available for someone to join Beiersdorf in this Regulatory Affairs Associate position. In this role, you will assist and support the organisation in maintaining an efficient, effective and contemporary Regulatory Affairs function that ensures the company complies with all relevant regulatory requirements in Australia and New Zealand.

The responsibilities of the role will include, but are not limited to:

• Prepare necessary submissions for medicines (including sunscreen products), medical devices and new ingredients consistent with requirements.
• Assess and review product ingredients for compatibility with regulatory requirements.
• Ensure currency and validity of the company’s database system of regulatory information necessary to meet the reporting and audit requirements of corresponding regulatory authorities.
• Prepare and submit data to regulatory authorities consistent with annual reporting obligations.
• Review all relevant product artwork and advertising material.
• Assist in and/or conduct additional regulatory, technical or other activities in support of regulatory matters as needed.

• Essential: Undergraduate qualifications in Physical Sciences (preferably Chemistry), Life Sciences, General Sciences, Pharmacy or Health Disciplines.
• Preferred: Post graduate studies in Cosmetic Science.
• 3 years’ experience in regulatory affairs related to complementary medicines, medical devices or cosmetics; or alternatively, 3 years in government statutory authorities.
• Ethical and trustworthy especially given exposure to very sensitive proprietary company information.
• Ability to work on multiple issues simultaneously with a good attention to detail and without constant direct supervision.
• Good written and oral communication skills and an ability to present complex or highly technical information to a less technical audience in a clear and understandable manner.
• Teamwork and cooperation, demonstrating enthusiasm and participating willingly and cooperatively with all identified relationships.

At Beiersdorf, we want to help people feel good about their skin – and our commitment goes far beyond caring for skin. For 100 years, we have developed innovative injury and skin care products for our well-known global brands such as Elastoplast, Leuko, NIVEA, Eucerin and La Prairie. We act according to our purpose, WE CARE BEYOND SKIN, and take responsibility for our consumers, our employees, the environment, and society.
Behind every brand, every product and every accomplishment are our more than 20,000 employees. It is for them that we live a culture of inclusion, respect and trust that is strongly aligned with our values CARE, COURAGE, SIMPLICITY and TRUST. We embrace diversity by valuing the uniqueness of each individual and being committed to equal opportunities for all.

PERKS

• Work from home 2 days per week
• On-site gym
• Additional leave days over and above Annual Leave
• Access to Health and Wellbeing programs (subsidised subscription of the Calm App)
• Over $100 of free products every year
• Paid Parental Leave
• Internal mentoring program
• Development plans to guide your career growth
• Employee Referral Program
• Tertiary Assistance Program for further education

If this sounds like the role for you, apply today!

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about theDanaher Business System which makes everything possible.

The Regulatory Affairs (RA) Lead is responsible for regulatory strategy, submissions, license management, in-country testing, and audit support for regulated countries throughout the Asia/Asia Pacific (APAC) region. The Lead will serve as the subject matter expert on cross-functional projects to ensure key performance indicators are met. Provide guidance and training to associates to ensure skilled competencies of global Regulatory standards and requirements at Cepheid.

This position is part of Regulatory Affairs, Global Market Expansion and will be located in Australia. The role will report to the Senior Director, Regulatory Affairs.

In this role, you will have the opportunity to:

• Serve in the following: preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals.
• Mentor and coach team on complex regulatory business initiatives.
• Manage and translate strategy/plan into goals by building repeatable processes that help manage the team’s sustained delivery on performance metrics.

The essential requirements of the job include:

• Bachelor's degree with 8+ years of related work experience, OR Master's degree in field with 6+ years of related work experience, OR Doctoral degree in field with 3+ years of related work experience; AND at least 2 years supervising people.
• Experience leading regulatory submissions and interactions with regulatory authorities (e.g. TGA) with an in-depth knowledge of global regulatory requirements, standards, and guidelines (including ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations).
• Strong written and communication skills; comfortable working in a dynamic multi-functional matrix organization.

Highly preferred requirements of the job include:

• Experience in supporting Quality Assurance activities.
• Technical experience within the in vitro diagnostic or medical device industries.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit .

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about theDanaher Business System which makes everything possible.

The Regulatory Affairs (RA) Lead is responsible for regulatory strategy, submissions, license management, in-country testing, and audit support for regulated countries throughout the Asia/Asia Pacific (APAC) region. The Lead will serve as the subject matter expert on cross-functional projects to ensure key performance indicators are met. Provide guidance and training to associates to ensure skilled competencies of global Regulatory standards and requirements at Cepheid.

This position is part of Regulatory Affairs, Global Market Expansion and will be located in Australia. The role will report to the Senior Director, Regulatory Affairs.

In this role, you will have the opportunity to:

• Serve in the following: preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals.
• Mentor and coach team on complex regulatory business initiatives.
• Manage and translate strategy/plan into goals by building repeatable processes that help manage the team’s sustained delivery on performance metrics.

The essential requirements of the job include:

• Bachelor's degree with 8+ years of related work experience, OR Master's degree in field with 6+ years of related work experience, OR Doctoral degree in field with 3+ years of related work experience; AND at least 2 years supervising people.
• Experience leading regulatory submissions and interactions with regulatory authorities (e.g. TGA) with an in-depth knowledge of global regulatory requirements, standards, and guidelines (including ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations).
• Strong written and communication skills; comfortable working in a dynamic multi-functional matrix organization.

Highly preferred requirements of the job include:

• Experience in supporting Quality Assurance activities.
• Technical experience within the in vitro diagnostic or medical device industries.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit .

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

Join to apply for the Regulatory Affairs Lead role at Cepheid

1 day ago Be among the first 25 applicants

Join to apply for the Regulatory Affairs Lead role at Cepheid

Get AI-powered advice on this job and more exclusive features.

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

The Regulatory Affairs (RA) Lead is responsible for regulatory strategy, submissions, license management, in-country testing, and audit support for regulated countries throughout the Asia/Asia Pacific (APAC) region. The Lead will serve as the subject matter expert on cross-functional projects to ensure key performance indicators are met. Provide guidance and training to associates to ensure skilled competencies of global Regulatory standards and requirements at Cepheid.

This position is part of Regulatory Affairs, Global Market Expansion and will be located in Australia. The role will report to the Senior Director, Regulatory Affairs.

In this role, you will have the opportunity to:

• Serve in the following: preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals.
• Mentor and coach team on complex regulatory business initiatives.
• Manage and translate strategy/plan into goals by building repeatable processes that help manage the team’s sustained delivery on performance metrics.
  
  

• Bachelor's degree with 8+ years of related work experience, OR Master's degree in field with 6+ years of related work experience, OR Doctoral degree in field with 3+ years of related work experience; AND at least 2 years supervising people.
• Experience leading regulatory submissions and interactions with regulatory authorities (e.g. TGA) with an in-depth knowledge of global regulatory requirements, standards, and guidelines (including ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations).
• Strong written and communication skills; comfortable working in a dynamic multi-functional matrix organization.
  
  

• Experience in supporting Quality Assurance activities.
• Technical experience within the in vitro diagnostic or medical device industries.
  
  

• Seniority level Not Applicable

• Employment type Full-time

• Job function Legal
• Industries Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Cepheid by 2x

Sydney, New South Wales, Australia 3 weeks ago

Millers Point, New South Wales, Australia 2 weeks ago

Warriewood, New South Wales, Australia 1 week ago

Sydney, New South Wales, Australia A$100,000.00-A$140,000.00 4 weeks ago

Sydney, New South Wales, Australia 1 month ago

Sydney, New South Wales, Australia 1 day ago

Macquarie Park, New South Wales, Australia 1 month ago

Sydney, New South Wales, Australia 1 month ago

Sydney, New South Wales, Australia 3 days ago

Sydney, New South Wales, Australia 1 month ago

Sydney, New South Wales, Australia 1 day ago

Sydney, New South Wales, Australia 3 days ago

Sydney, New South Wales, Australia 1 day ago

St Leonards, New South Wales, Australia 1 week ago

Sydney, New South Wales, Australia 4 days ago

Sydney, New South Wales, Australia 2 days ago

Sydney, New South Wales, Australia 2 days ago

Sydney, New South Wales, Australia 2 weeks ago

Sydney, New South Wales, Australia 2 weeks ago

Parramatta, New South Wales, Australia 1 week ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

1 month ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from MedReleaf Australia

Job location: Anywhere in Australia (Remote)

Hours: 38 hours per week, Monday – Friday

About us:

We’re MedReleaf Australia – a leading provider of alternative medicine in Australia, dedicated to improving the lives of others. We’re paving the way for the industry with a talented team of professionals who help introduce holistic healthcare solutions across Australia. Together, we’ve defined what we call the MedReleaf Way - a secret recipe for success that allows us to be a trusted provider, educator, and leader in the industry for our community - and this is what makes us a special place to work.

We’re in an exciting period of growth and are on a mission to expand our team across Australia with a range of dynamic opportunities. We’re now part of a global network of Aurora Cannabis, a world-leading integrated medical cannabis company with a strong reputation for setting the global standard in alternative medicine care. With a strong presence in markets including Canada, Europe, Australia, and New Zealand, Aurora brings invaluable expertise that will support our growth and continue to enable us to deliver exceptional patient care within our community. If this is not the role for you, check out our Global Aurora Careers Page to find the perfect opportunity.

About you:

Plant your roots with us as our next Director Regulatory Affairs where you will play critical leadership role overseeing regulatory compliance, public policy development and other strategic initiatives critical for MedReleaf Australia’s operations in Australia and New Zealand. You will be responsible for developing and executing regulatory strategies to further our regulatory and commercial interests, ensuring compliance with applicable laws and industry standards, and serving as the primary interlocutor with regulatory authorities and public policy leads, including the Ministry of Health (NZ), New Zealand Medicinal Cannabis Council (NZ), Therapeutic Goods Administration (TGA), the Office of Drug Control (ODC) and Australian Health Practitioner Regulation Agency (AHPRA).

In this role you will ensure the integrity of our products and services while driving alignment with regulatory frameworks and influencing policy to support business objectives. Critical to this role will be strengthening our position as a trusted leader in the medicinal cannabis industry and ensures sustainable growth and compliant practices across the ANZ market. Sound exciting? Here is a little more…

As the Director Regulatory Affairs you will oversee…

Regulatory Leadership and Strategy

• Develop and oversee the execution of comprehensive regulatory strategies to support product development, registration, licensing, and approval processes across ANZ.
• Ensure ongoing compliance with local, national, and international regulatory requirements.
• Act as a strategic advisor on regulatory matters, collaborating with senior leadership to align regulatory priorities with business goals.
• Monitor and evaluate regulatory trends and provide forward-looking guidance to anticipate and address potential challenges.

Public Policy Development

• Working within the Centre of Excellence, collaborate with colleagues to support the development and implementation of government relations strategies to influence government policies, regulations, and legislation supporting the growth of the medicinal cannabis industry in the ANZ market.
• Leverage opportunities to support MRA/Aurora’s participation in local/regional industry associations or related special events that are focused on broadening relationships with government decision-makers, facilitating access to medical cannabis for patients, and other objectives that are in alignment with Aurora’s corporate outcomes in ANZ.
• Collaborate with internal teams, including Legal, Regulatory, and Quality Assurance, to ensure government relations efforts are aligned with organizational objectives.

Team Oversight and Cross-Functional Collaboration

• Lead, mentor, and manage the Regulatory Affairs and Compliance team across ANZ to ensure high performance and professional development.
• Collaborate with R&D, Quality Assurance, Legal, and other teams to integrate regulatory considerations into product development, manufacturing, and marketing activities.
• Provide training to internal stakeholders on regulatory changes and ensure organizational readiness for compliance.

Regulatory Operations and Agency Engagement

• Serve as the primary interlocutor with regulatory authorities, including but not limited to Therapeutic Goods Administration (TGA), the Office of Drug Control (ODC), Australian Health Practitioner Regulation Agency (AHPRA), Ministry of Health (NZ) and New Zealand Medicinal Cannabis Council (NZ), managing all submissions, queries, and inspections.
• Oversee the preparation and submission of regulatory documentation, ensuring accuracy and adherence to timelines.
• Build and maintain strong relationships with regulatory agencies, ensuring effective communication and advocacy for the organization’s interests.

Compliance and Risk Management

• Oversee the implementation and maintenance of the Quality Management System (QMS), ensuring adherence to regulatory and quality standards.
• Manage all relevant licenses, permits, and certifications, ensuring timely renewals and compliance with applicable regulations with applicable team members.
• Conduct internal audits and risk assessments, implementing corrective and preventive actions to address quality or compliance gaps.
• Ensure the timely resolution of complaints, adverse events, and quality issues in accordance with regulatory guidelines.

Operational Excellence and Continuous Improvement

• Lead initiatives to optimize the Business’ SAS program, Portal rollout, and CSO network expansion, ensuring seamless execution and compliance.
• Oversee the review and approval of product labelling, barcodes, and packaging materials to meet regulatory requirements.
• Collaborate with external partners, vendors, and industry stakeholders to ensure compliance and support regulatory reform efforts.

You’ll be set up for success if you have…

• Bachelor’s degree in Law, Regulatory Affairs, or a related field.
• 8 + years of progressive experience in regulatory affairs, compliance, and quality management, with at least 2–3 years within the pharmaceutical or medicinal cannabis industry preferred.
• Proven success in preparing and submitting regulatory documents for product approvals and managing regulatory inspections.
• Demonstrated experience working with regulatory authorities, such as but not limited to the TGA and ODC, Ministry of Health (NZ) and New Zealand Medicinal Cannabis Council (NZ), with a thorough understanding of regulatory requirements in Australia and New Zealand.
• Experience working in a global public and matrix environment, ideally in medical cannabis.
• Experience navigating complex, matrix, resource-constrained environments, managing ambiguity, and adapting to continuous change while maintaining a focus on organizational goals.

We can’t wait to meet you if you have…

• Exceptional regulatory affairs expertise with in-depth knowledge of regulatory processes, including product registration, submissions, and compliance, with a strong understanding of pharmaceutical regulations, guidelines, and quality standards, including Good Manufacturing Practice (GMP) principles. Possesses a track record of problem resolution.
• Strong communication skills for effective interaction with regulatory agencies and internal stakeholders.
• Excellent project management skills to ensure timely and accurate submission of regulatory documents.
• Strong analytical skills for interpreting and applying regulatory requirements to business processes.
• Strong judgment to evaluate options and implement effective strategies to address compliance, regulatory, and government relations needs.
• Understanding of corporate strategy, market dynamics, and how regulatory and government relations influence business objectives with experience working in matrix global environments and influencing decision-making.
• Proven ability to lead, mentor, and manage cross-functional teams, fostering collaboration and high performance.
• Competence in managing regulatory and reputational risks, ensuring effective responses to compliance or policy-related challenges.
• Demonstrated ability to lead with courage and integrity, speak truth to power, and foster collaboration to drive success, while embodying our values of Winning Together, Courage, Accountability, and Compassion in all actions
• Possesses the ability to adapt quickly , while maintaining focus and a high degree of accuracy maneuvering complex data in an environment of everchanging deadlines, priorities, and requirements

This role requires travel, schedule flexibility, and a satisfactory Police and Reference Check.

With us, you will find a place where you belong and love where you work with a whole crop of benefits like the following:

• Competitive Compensation: Enjoy a base salary, super, annual bonus (when applicable) and more!
• Professional Development: Unlock robust growth opportunities with access to conferences, workshops, webinars, a study support program for tuition, and career development
• Work-Life Balance: Prioritize your well-being with our flexible work structure, offering remote work options, annual and personal leave options
• Vibrant Culture: Join a dynamic team with exciting events like sales celebrations, holiday parties, volunteer initiatives, and product launches that make every day memorable

Next steps:

Submit your resume through LinkedIn by clicking “Apply Now”.

• Seniority level Director

• Employment type Full-time

• Job function Legal, General Business, and Management
• Industries Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at MedReleaf Australia by 2x

Get notified about new Director of Regulatory Affairs jobs in Australia .

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about theDanaher Business System which makes everything possible.

The Regulatory Affairs (RA) Lead is responsible for regulatory strategy, submissions, license management, in-country testing, and audit support for regulated countries throughout the Asia/Asia Pacific (APAC) region. The Lead will serve as the subject matter expert on cross-functional projects to ensure key performance indicators are met. Provide guidance and training to associates to ensure skilled competencies of global Regulatory standards and requirements at Cepheid.

This position is part of Regulatory Affairs, Global Market Expansion and will be located in Australia. The role will report to the Senior Director, Regulatory Affairs.

In this role, you will have the opportunity to:

• Serve in the following: preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals.
• Mentor and coach team on complex regulatory business initiatives.
• Manage and translate strategy/plan into goals by building repeatable processes that help manage the team’s sustained delivery on performance metrics.

The essential requirements of the job include:

• Bachelor's degree with 8+ years of related work experience, OR Master's degree in field with 6+ years of related work experience, OR Doctoral degree in field with 3+ years of related work experience; AND at least 2 years supervising people.
• Experience leading regulatory submissions and interactions with regulatory authorities (e.g. TGA) with an in-depth knowledge of global regulatory requirements, standards, and guidelines (including ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations).
• Strong written and communication skills; comfortable working in a dynamic multi-functional matrix organization.

Highly preferred requirements of the job include:

• Experience in supporting Quality Assurance activities.
• Technical experience within the in vitro diagnostic or medical device industries.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit .

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about theDanaher Business System which makes everything possible.

The Regulatory Affairs (RA) Lead is responsible for regulatory strategy, submissions, license management, in-country testing, and audit support for regulated countries throughout the Asia/Asia Pacific (APAC) region. The Lead will serve as the subject matter expert on cross-functional projects to ensure key performance indicators are met. Provide guidance and training to associates to ensure skilled competencies of global Regulatory standards and requirements at Cepheid.

This position is part of Regulatory Affairs, Global Market Expansion and will be located in Australia. The role will report to the Senior Director, Regulatory Affairs.

In this role, you will have the opportunity to:

• Serve in the following: preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals.
• Mentor and coach team on complex regulatory business initiatives.
• Manage and translate strategy/plan into goals by building repeatable processes that help manage the team’s sustained delivery on performance metrics.

The essential requirements of the job include:

• Bachelor's degree with 8+ years of related work experience, OR Master's degree in field with 6+ years of related work experience, OR Doctoral degree in field with 3+ years of related work experience; AND at least 2 years supervising people.
• Experience leading regulatory submissions and interactions with regulatory authorities (e.g. TGA) with an in-depth knowledge of global regulatory requirements, standards, and guidelines (including ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations).
• Strong written and communication skills; comfortable working in a dynamic multi-functional matrix organization.

Highly preferred requirements of the job include:

• Experience in supporting Quality Assurance activities.
• Technical experience within the in vitro diagnostic or medical device industries.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit .

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.