Senior Regulatory Affairs Specialist
1 day ago
We're seeking a seasoned professional to spearhead our Regulatory Affairs team in the ANZ affiliate. As a key member of our organization, you will be responsible for leading projects and collaborating cross-functionally to ensure compliance with relevant legislations and regulations.
- Contribute to the strategic direction and vision for the RA organization at the country level.
- Ensure timely fulfillment of regulatory requirements linked to local licenses and market authorizations.
- Participate in resource and budget planning, as well as contribute to process improvements.
- Develop and lead complex regulatory submissions, facilitating effective internal and external communication.
- Initiate and drive local improvements and participate in global process enhancements that impact RA and other departments.
- Review and approve promotional materials.
- Maintain compliance with local laws and regulations, and may act as the local Gilead representative when required.
Requirements:
- 12+ years of experience in RA or a related field with a Bachelor's degree, or 10+ years of experience with an advanced degree.
- Exceptional knowledge of regulatory requirements, including ICH guidelines and regional regulations.
- Strong understanding of quality assurance, promotional review, pharmacovigilance, and market access principles.
- Proven ability to work effectively in cross-functional project teams and lead them.
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