Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)
AbbVie
August 10, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid)
Responsibilities:
- Develop and implement US/Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Ensure GRPT regulatory strategies are implemented and maintained to meet changing regulatory and business needs.
- Gather data to support filings, FDA inquiry responses, and registration maintenance for commercialization.
- Support development and execution of regulatory strategy for products/indications in a Therapeutic Area.
- Serve as HA (Health Authority) liaison; interface with FDA for meetings/teleconferences; coordinate FDA briefing packages and responses.
- Advise internal teams on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Negotiate and make decisions on project issues with cross-functional impact.
- Assist in development and training of staff.
- Prepare/review regulatory submissions and ensure complete, timely Health Authority responses during review.
- Support regulatory submission and approval process; apply regulatory knowledge across therapeutic areas.
- Recommend and implement changes to complex projects based on US/Canada regulations, guidances, and corporate policies.
- Present regulatory information to cross-functional areas; operate in compliance with regulations and the Quality Dossier Program (QDP).
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
- Experience interfacing with government regulatory agencies
Preferred:
- 2–3 years in pharmaceutical regulatory activities; global regulatory experience
- Advanced degree; certifications
Required Skills:
- Excellent negotiation and problem-solving; builds consensus
- Strong written/oral communication across organization
- Delivers challenging messages without damaging relationships
- Proven skill implementing successful US/Canada regulatory strategies
Benefits (if eligible):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k)
- Eligible for long-term incentive programs
Responsibilities:
- Develop and implement US/Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Ensure GRPT regulatory strategies are implemented and maintained to meet changing regulatory and business needs.
- Gather data to support filings, FDA inquiry responses, and registration maintenance for commercialization.
- Support development and execution of regulatory strategy for products/indications in a Therapeutic Area.
- Serve as HA (Health Authority) liaison; interface with FDA for meetings/teleconferences; coordinate FDA briefing packages and responses.
- Advise internal teams on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Negotiate and make decisions on project issues with cross-functional impact.
- Assist in development and training of staff.
- Prepare/review regulatory submissions and ensure complete, timely Health Authority responses during review.
- Support regulatory submission and approval process; apply regulatory knowledge across therapeutic areas.
- Recommend and implement changes to complex projects based on US/Canada regulations, guidances, and corporate policies.
- Present regulatory information to cross-functional areas; operate in compliance with regulations and the Quality Dossier Program (QDP).
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
- Experience interfacing with government regulatory agencies
Preferred:
- 2–3 years in pharmaceutical regulatory activities; global regulatory experience
- Advanced degree; certifications
Required Skills:
- Excellent negotiation and problem-solving; builds consensus
- Strong written/oral communication across organization
- Delivers challenging messages without damaging relationships
- Proven skill implementing successful US/Canada regulatory strategies
Benefits (if eligible):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k)
- Eligible for long-term incentive programs