Regulatory Affairs Director
1 week ago
We 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 reputation for successfully promoting partner products in ANZ and SEA. With a steadfast commitment to patient care and delivering value to customers, they foster a culture of innovation and entrepreneurship.
Reporting to the CEO, your responsibilities will include:
- Managing the submission process and working closely with health authorities TGA and Medsafe and SEA stakeholders.
- Leading the review, interpretation, development, and submission of technical files and regulatory dossiers.
- Providing input on possible new ways of drug development and registration and work on proposals for business development.
- Managing and maintaining all regulatory registrations in accordance with the latest standards.
- Working cross-functionally with marketing and sales teams as part of the leadership team.
- Supporting, growing, and developing the Regulatory Affairs team.
- Overseeing other related areas and functions to ensure all Adverse Events, product, and/or quality complaints are appropriately addressed and processed.
To be successful in this role, you will have:
- 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
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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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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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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...
