Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology

Senior Manager RA, Global Reg Strategy US & Canada – Immunology is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or products in development. Ensures regulatory strategies are implemented and maintained in line with changing regulatory and business needs, including gathering data to support filings, responses, and registration maintenance to enable commercialization meeting US and Canada regulatory requirements.

Responsibilities:
- Support development and execution of regulatory strategy for products within a Therapeutic Area.
- Serve as HA liaison; interface with FDA; coordinate FDA meeting briefing packages and responses; advise internal stakeholders on Regulatory/FDA issues.
- Independently handle negotiation and decision-making on cross-functional project issues; assist in staff training.
- Prepare and review regulatory submissions; ensure complete/timely responses to Health Authorities during review.
- Support regulatory submission and approval process.
- Recommend and implement changes for difficult projects using regulatory knowledge, guidance, and corporate policies.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations and company Quality Dossier Program (QDP).
- Hybrid schedule: 3 days in office, 2 days remote from Illinois & New Jersey AbbVie headquarters.

Qualifications:
- Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
- Advanced degree and certifications a plus.
- 6+ years Regulatory/R&D/industry experience; 2–3 additional years in pharmaceutical regulatory activities preferred.
- Excellent negotiation, problem-solving, consensus-building, and written/oral communication skills.
- Experience interfacing with government agencies; complex/matrix environment experience. Global regulatory experience a plus.