Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)
AbbVie124500 - 236500
Florham ParkFull TimeData Science
Remotely
Listed on 2 job boards, which is a stronger signal than one board alone.
regulatory affairsregulatory strategypharmaall otherhealth authoritiesus fdamatrix managementquality dossier program
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Job Description
📋 Description
- Develop and implement US and Canada regulatory strategies for assigned products.
- Coordinate regulatory strategy with cross-functional teams to meet business needs.
- Serve as HA liaison and interface with FDA for meetings and briefing packages.
- Support regulatory submissions and respond to Health Authorities timely.
- Contribute to regulatory strategy development and training of staff.
- Represent regulatory in cross-functional initiatives affecting product strategy.
🎯 Requirements
- Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
- 6 years Regulatory, R&D, or Industry experience
- Experience interfacing with government regulatory agencies
- Excellent negotiation and communication skills
- Ability to deliver messages without compromising business relationships
- Proven ability to implement US and Canada regulatory strategies
🎁 Benefits
- AbbVie is an equal opportunity employer
- Comprehensive benefits including PTO and health insurance
- Eligible for long-term incentive programs
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