Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)
AbbVie124500 - 236500
South San FranciscoFull TimeData Science
Remotely
Listed on 2 job boards, which is a stronger signal than one board alone.
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Job Description
📋 Description
- The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible
- Ensure regulatory strategies defined within the GRPT are implemented and maintained in line with
- Gather data to support filings, responses to inquiries, and registration maintenance to enable
- Interface with FDA meetings, teleconferences, and prepare FDA briefing packages and responses.
- Advise internal teams on Regulatory/FDA issues including Public Affairs, Clinical Development
- Contribute to preparation and review of regulatory submissions and maintain alignment with US and
Qualifications
- Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
- 6 years Regulatory, R&D, or Industry-related experience
- Experience in a complex/matrix environment; interfacing with government regulatory agencies
- 2-3 years in pharmaceutical regulatory activities; global regulatory experience a plus
- Excellent negotiation and communication skills; ability to deliver challenging messages while
- Proven skill at implementing US and Canada regulatory strategies
🎁 Benefits
- AbbVie offers a comprehensive benefits package including paid time off, medical/dental/vision
- Long-term incentive programs
- Equal Employment Opportunity; includes Veterans/Disabled
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