Regulatory Affairs Specialist
5 days ago
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes 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, ensuring compliance with ICH requirements and company policies.
- Submit marketing authorization and variations, as well as safety reports, amendments, supplements, and clinical trial applications as required.
- Provide local regulatory expertise for labeling changes and contribute to the preparation of country-specific labeling.
- Ensure product packaging and associated information is updated and maintained in accordance with product licenses.
- Participate in group meetings and present project status updates and strategy approaches to complex programs.
- 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.
- Integrity (always doing the right thing)
- Teamwork (collaborating in good faith)
- Excellence (working at a high level of commitment and capability)
- Accountability (taking personal responsibility)
- Inclusion (encouraging diversity)
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Regulatory Affairs Specialist
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Melbourne, Victoria, Australia STERIS Canada Corporation Full time{"h3": "Job Title: Regulatory Affairs Specialist", "p": "At STERIS, we help our customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. Our team is dedicated to supporting the development and implementation of regulatory policies that ensure the highest level of quality...
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Melbourne, Victoria, Australia Energy Australia Full time{"title": "Regulatory Pipeline Lead", "description": "About UsWe're a leading energy provider in Australia, committed to a clean energy future for all. Our purpose is to lead and accelerate the clean energy transformation, and we're proud of our progress so far.About the RoleWe're looking for a Regulatory Pipeline Lead to join our team. As a key member of...
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Regulatory Affairs Manager
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Regulatory Affairs Manager
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Regulatory Affairs Specialist
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Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeAbout Northern TrustNorthern Trust is a leading global financial institution with a rich history dating back to 1889. As a Fortune 500 company, we have established ourselves as a trusted partner for individuals, families, and institutions seeking innovative financial services and guidance.Our commitment to service, expertise, and integrity has enabled us to...
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Regulatory Affairs Specialist
1 week ago
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