Regulatory Affairs Director
2 weeks ago
We are seeking a highly skilled Regulatory Affairs professional to lead our regulatory strategy and ensure compliance with regulatory requirements. As a key member of our team, you will be responsible for managing the submission process, working closely with health authorities, and leading the review and interpretation of technical files and regulatory dossiers.
Key Responsibilities:- Manage the submission process and work closely with health authorities TGA and Medsafe and SEA stakeholders.
- Lead the review, interpretation, development, and submission of technical files and regulatory dossiers.
- Provide input on possible new ways of drug development and registration and work on proposals for business development.
- Manage and maintain all regulatory registrations in accordance with the latest standards.
- Work cross-functionally with marketing and sales teams as part of the leadership team.
- Support, grow, and develop the Regulatory Affairs team.
- Oversee other related areas and functions to ensure all Adverse Events, product, and/or quality complaints are appropriately addressed and processed.
- Tertiary scientific qualification in Life Sciences.
- An extensive track record in efficient submissions of biologicals and orphan drugs.
- Strong strategic and executional expertise across multiple launches.
- External stakeholder management.
- Exposure to APAC markets will be advantageous.
- Strong presentation and relationship-building skills.
- Excellent organizational skills and attention to detail.
Candidates with a background in biologicals and orphan drugs will be highly regarded. This is a truly exciting opportunity to make your impact in a specialty therapeutic area with a fast-growing business.
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Regulatory Affairs Director
1 week 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...
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Regulatory Affairs Director
3 weeks ago
Melbourne, Victoria, Australia Heng & Hurst Full timeLead Regulatory Affairs in a Growing BusinessWe are seeking a seasoned Regulatory Affairs professional to lead our team in Melbourne, Australia. As Head of Regulatory Affairs, you will be responsible for managing the submission process, working closely with health authorities, and leading the review and interpretation of technical files and regulatory...
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Regulatory Affairs Director
2 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...
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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...
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Regulatory Affairs Specialist
4 weeks ago
Melbourne, Victoria, Australia Gilead Sciences Full timeJob DescriptionGilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Our mission is to create a healthier world for all people, and we're looking for talented individuals to join our team.Job SummaryWe are seeking a knowledgeable and motivated...
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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...
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Regulatory Affairs Director
2 weeks ago
Melbourne, Victoria, Australia Heng & Hurst Full timeJob Title: Head of Regulatory AffairsWe are seeking an experienced Head of Regulatory Affairs to join our team at Heng & Hurst. As a key member of our leadership team, you will be responsible for managing the submission process and working closely with health authorities TGA and Medsafe and SEA stakeholders.Key Responsibilities:Manage the submission process...
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Director of Public Affairs
1 month ago
Melbourne, Victoria, Australia SHK Full timeAbout the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...
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Director of Public Affairs
4 weeks ago
Melbourne, Victoria, Australia SHK Full timeAbout the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...
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Director of Public Affairs
1 month ago
Melbourne, Victoria, Australia SHK Full timeAbout the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...
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Director of Public Affairs
3 weeks ago
Melbourne, Victoria, Australia SHK Full timeAbout the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...
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Director of Public Affairs
3 weeks ago
Melbourne, Victoria, Australia SHK Full timeAbout the RoleThe Director, Public Affairs is a pivotal executive role responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This role requires fostering strong...
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Regulatory Affairs Manager
3 weeks ago
Melbourne, Victoria, Australia Gilead Sciences Full time{"title": "Regulatory Affairs Manager", "content": "Job SummaryGilead Sciences is seeking a highly skilled Regulatory Affairs Manager to join our team in Melbourne, Australia. As a key member of our Regulatory Affairs department, you will be responsible for preparing regulatory submissions and providing local expertise for labelling changes and...
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Director of Public Affairs
3 weeks ago
Melbourne, Victoria, Australia Environment Protection Authority Full timeAbout the RoleThe Environment Protection Authority is seeking a highly experienced and skilled Director of Public Affairs to lead the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This...
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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...
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Public Affairs Director
3 weeks ago
Melbourne, Victoria, Australia Treasury Wine Estates Full timeAbout the RoleWe are seeking a highly skilled and experienced Public Affairs Director to lead our global Public Affairs team in shaping Government & Industry Relations and public policy initiatives. Reporting to the Global Director of Corporate Affairs, this pivotal role will oversee a team of 3 Public Affairs experts based across America, Australia, and the...
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Director of Public Affairs
1 month ago
Melbourne, Victoria, Australia SHK Full timeAbout the RoleThe Director, Public Affairs is a senior executive position responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This pivotal role is suited to an...
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Director of Public Affairs
2 weeks ago
Melbourne, Victoria, Australia SHK Asia Pacific Full timeAbout the RoleThe Director, Public Affairs is a key leadership position responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste, developing and implementing the EPA's strategic engagement, and raising awareness of the EPA's role.This pivotal role is suited to an...
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Director of Public Affairs
1 month ago
Melbourne, Victoria, Australia SHK Full timeAbout the RoleThe Director, Public Affairs is a senior executive position responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste. This role requires a proven executive leader with a record of achievement in strategic advisory areas, regulatory or public sector...
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Director of Public Affairs
1 month ago
Melbourne, Victoria, Australia SHK Full timeAbout the RoleThe Director, Public Affairs is a senior executive position responsible for leading the Public Affairs Branch in promoting action to prevent harm to the environment and human health from pollution and waste. This role requires a proven executive leader with a record of achievement in strategic advisory areas, regulatory or public sector...