Regulatory Affairs Manager
6 hours ago
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need.
We are committed to improving the care of patients living with life-threatening diseases around the world.
Job DescriptionWe are seeking a knowledgeable and motivated professional to join our Regulatory Affairs team in Melbourne, Australia.
The successful candidate will assume a 12-month contract and report to the Senior Director, Regulatory Affairs.
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 authorization and variations, as well as other submissions such as safety reports, amendments, supplements, clinical trial applications, and authorizations.
- 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 the product licenses.
- Participate in group meetings and local and global product submission team meetings, and present project status updates and strategy approaches to complex programs/projects.
- Initiate or contribute to local process improvements that have an impact on the working of the Regulatory Affairs function or other departments.
- 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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