Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)
AbbVie124500 - 236500
IrvineFull TimeHealthcare
Remotely
Listed on 2 job boards, which is a stronger signal than one board alone.
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Job Description
📋 Description
- Develop US & Canada regulatory strategy for assigned products
- Implement regulatory strategy per GRPT guidance
- Gather data for filings and responses to authorities
- Interface with FDA for meetings and briefing packages
- Advise internal teams on Regulatory/FDA issues
- Prepare and review regulatory submissions per US/Canada rules
🎯 Requirements
- Bachelor’s degree in a related field
- 6 years Regulatory, R&D, or industry experience
- Experience in complex matrix environments
- Experience interfacing with regulatory agencies
- Strong negotiation and communication skills
- Ability to deliver regulatory strategies for US/Canada
🎁 Benefits
- Comprehensive benefits package including PTO and health insurance
- Participation in long-term incentive programs
- AbbVie equal opportunity employer
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