Regulatory Affairs Specialist
4 weeks ago
About the Role
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. We are seeking a knowledgeable and motivated professional to join our Regulatory Affairs team in Melbourne, Australia.
Key Responsibilities
- Prepare regulatory submissions for investigational and commercial products for Australia and New Zealand in line with ICH requirements and scientific and company policies and procedures.
- Submit marketing authorisation and variations, as well as safety reports, amendments, supplements, clinical trial applications, and authorizations.
- Provide local regulatory expertise for labelling changes and to submission teams on specified projects and topics.
- Contribute to the preparation of country-specific labelling.
- Ensure product packaging and associated information is updated and maintained in accordance with the product licenses.
- Participate in group meetings and local and global product submission team meetings, presenting project status updates and strategy approaches to complex programs/projects.
- Develop and maintain knowledge of Australian regulatory requirements, including ICH requirements and global regulatory requirements.
Requirements
- 8+ years of experience in Australian Regulatory Affairs.
- Extensive experience negotiating and interacting with the Therapeutic Goods Administration.
- Ability to perform as a senior member of a team with diverse membership from all functions and levels of the company.
- Degree in a scientific field is preferred.
About Gilead Sciences
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. We are committed to a diverse workforce and an inclusive environment.
-
Regulatory Affairs Specialist
1 week ago
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeJob OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our Global Regulatory Affairs Office (GRAO). This key role will provide subject matter expertise across a multi-year regulatory and risk program, focusing on risk management, remediation of regulatory and audit findings, and administration of regulatory affairs.
-
Regulatory Affairs Specialist
1 week ago
Melbourne, Victoria, Australia DoorDash, Inc. Full timeAbout DoorDashWe're a technology and logistics company that empowers local economies by providing fast, reliable, and affordable delivery services to consumers. Our mission is to make it possible for anyone to get what they need in under an hour.Job OverviewWe're looking for a highly skilled Regulatory Affairs Specialist to join our Policy Development and...
-
Regulatory Affairs Specialist
2 weeks ago
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeAbout Northern Trust:As a globally recognized and award-winning financial institution, Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions.We remain true to our enduring principles of service, expertise, and integrity, leveraging our financial experience and...
-
Regulatory Affairs Executive
2 weeks ago
Melbourne, Victoria, Australia Pharmiweb Full timeJob Title:Regulatory Affairs ExecutiveAbout the Role:Pharmiweb is seeking an experienced Regulatory Affairs Executive to lead our regulatory compliance efforts. The ideal candidate will have a strong background in regulatory affairs and excellent leadership skills.Main Responsibilities:Develop and implement regulatory strategies to ensure compliance with...
-
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeAbout Northern Trust: A Financial Institution with a Global PresenceFounded in 1889, Northern Trust is a renowned Fortune 500 company that has been serving the world's most successful individuals, families, and institutions with innovative financial services and guidance.The Global Regulatory Affairs Office (GRAO) plays a crucial role in enhancing risk...
-
Planning Specialist
6 days ago
Melbourne, Victoria, Australia Public Sector People Full timeAbout the Role:Review and process planning applications in accordance with statutory requirements Provide clear and timely advice to stakeholders Ensure compliance with planning regulations and local policies We are seeking an experienced Planning Specialist to join our team. This is a 3-month temporary role, with the potential for extension, offering a...
-
Regulatory Affairs Director
4 weeks ago
Melbourne, Victoria, Australia Heng & Hurst Full timeJob SummaryThis is a unique opportunity to lead a growing business from a regulatory affairs perspective with multiple launches and a dynamic & entrepreneurial team. As the Head of Regulatory Affairs, you will be responsible for managing the submission process and working closely with health authorities TGA and Medsafe and SEA stakeholders.Key...
-
Regulatory Affairs Specialist
6 days ago
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeNorthern Trust Company Australia, a leading financial institution, seeks an experienced Regulatory Affairs Specialist to support the enhancement of our risk management and controls. This role sits within the Global Regulatory Affairs Office (GRAO) and involves providing subject matter expertise across a multi-year regulatory and risk program.The ideal...
-
Regulatory Affairs Director
2 weeks ago
Melbourne, Victoria, Australia Heng & Hurst Full timeThis is a newly created senior leadership opportunity based in Melbourne, Australia, where you will have strategic and operational responsibility for a growing business. You will be part of a dynamic and entrepreneurial team, working closely with the CEO and other experienced executives to drive business growth through regulatory affairs.As the Head of...
-
Regulatory Affairs Director
4 weeks ago
Melbourne, Victoria, Australia Heng & Hurst Full timeRegulatory Affairs Director OpportunityWe are excited to be partnering with an international biopharmaceutical company dedicated to providing new and innovative therapies and technologies that fulfill unique unmet needs in our community.As a leader in the commercialization of products across various therapeutic areas, they have established a strong...
-
Melbourne, Victoria, Australia Gilead Sciences Full timeGilead Sciences is a research-based biopharmaceutical company committed to creating innovative medicines for unmet medical needs. Our team in Melbourne, Australia, is seeking a highly skilled Regulatory Affairs professional to join our cross-functional department.Job DescriptionThis 12-month contract role will report to the Senior Director, Regulatory...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeJob SummaryThis is an exciting opportunity to lead the Regulatory Affairs and Pharmacovigilance functions for a dynamic pharmaceutical company.About the RoleAs the Regional Head of Regulatory Affairs and Pharmacovigilance, you will be responsible for leading a team of seasoned professionals in developing and executing regulatory strategies to drive product...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeHealthcare Professionals Group is seeking a highly skilled and experienced Regional Director of Regulatory Affairs and Pharmacovigilance to lead and shape regulatory strategy and ensure compliance across Australia, New Zealand, and regional markets.About the OpportunityThis newly created role is targeted at a seasoned professional with extensive experience...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeJob Title: Regional Regulatory Affairs and Pharmacovigilance DirectorAbout the Role:This is a newly created role with a focus on leading and shaping regulatory strategy and ensuring compliance across Australia, New Zealand, and regional markets. The successful candidate will oversee both the Regulatory Affairs and Pharmacovigilance functions, providing...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeCompany Overview:We are proud to partner with a dynamic biopharmaceutical company that has experienced great success, recognised as an innovative leader across multiple portfolios and specialty therapy areas. Their market-leading products have prolonged lives, enhanced the quality of life, and cured patients from debilitating diseases.About the...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeEstablish a Strong Regulatory Presence in ANZ and APACAbout the OpportunityThis newly created leadership role seeks an accomplished Head of Regulatory Affairs and Pharmacovigilance to lead and shape regulatory strategy, ensuring compliance across Australia, New Zealand, and regional markets. In this pivotal position, you will oversee both Regulatory Affairs...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Director to lead our team in ensuring compliance and shaping regulatory strategy across Australia, New Zealand, and regional markets.Key Responsibilities:Develop and execute regulatory strategies to drive product portfolio expansion.Oversee regulatory compliance across the ANZ and APAC regions...
-
Corporate Affairs Specialist
5 days ago
Melbourne, Victoria, Australia Group People & Corporate Affairs Full timeAbout the RoleWe are seeking a passionate and dedicated Corporate Affairs Specialist to join our Group People & Corporate Affairs team. In this role, you will have the opportunity to work across various initiatives, including community partnerships, environment, social, and governance projects.Key ResponsibilitiesSupport the development and implementation of...
-
Regulatory Compliance Specialist
7 days ago
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeAbout 023 Northern Trust Company AustraliaWe are a globally recognized, award-winning financial institution with over 130 years of financial experience. Our company has been in continuous operation since 1889 and provides innovative financial services to the world's most sophisticated clients.Our commitment to service, expertise, and integrity has earned us...
-
Regulatory Compliance Specialist
2 weeks ago
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeAbout Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.We are proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring principles of...
