Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology
AbbVie
June 27, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
Senior Manager RA, Global Reg Strategy US & Canada - Immunology
Responsibilities:
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Ensure regulatory strategies are implemented and maintained in line with changing regulatory and business needs.
- Identify and gather data to support filings, responses to inquiries, and registration maintenance for commercialization.
- Serve as HA liaison; interface with FDA; coordinate preparation and completion of FDA meeting briefing packages and responses.
- Advise internal stakeholders (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently negotiate and make decisions on cross-functional project issues; assist with staff training.
- Prepare and review regulatory submissions to US/Canada requirements and ensure complete, timely responses to Health Authorities.
- Support regulatory submission and approval process; apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes to difficult projects based on regulations/guidances, corporate policies, and business considerations.
- Present pertinent regulatory information to cross-functional teams.
- Operate in compliance with regulations and company guidance aligned with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications:
Required: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related; 6 years’ Regulatory, R&D, or Industry-related experience; proven skill implementing US/Canada regulatory strategies; experience in complex/matrix environments; negotiation/problem-solving and strong written/oral communication; experience interfacing with government regulatory agencies.
Preferred: 2–3 additional years in pharmaceutical regulatory activities; advanced degree; certifications; global regulatory experience.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) (eligible employees); long-term incentive program eligibility.
Application instructions:
- None stated.
Responsibilities:
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Ensure regulatory strategies are implemented and maintained in line with changing regulatory and business needs.
- Identify and gather data to support filings, responses to inquiries, and registration maintenance for commercialization.
- Serve as HA liaison; interface with FDA; coordinate preparation and completion of FDA meeting briefing packages and responses.
- Advise internal stakeholders (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Independently negotiate and make decisions on cross-functional project issues; assist with staff training.
- Prepare and review regulatory submissions to US/Canada requirements and ensure complete, timely responses to Health Authorities.
- Support regulatory submission and approval process; apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes to difficult projects based on regulations/guidances, corporate policies, and business considerations.
- Present pertinent regulatory information to cross-functional teams.
- Operate in compliance with regulations and company guidance aligned with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications:
Required: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related; 6 years’ Regulatory, R&D, or Industry-related experience; proven skill implementing US/Canada regulatory strategies; experience in complex/matrix environments; negotiation/problem-solving and strong written/oral communication; experience interfacing with government regulatory agencies.
Preferred: 2–3 additional years in pharmaceutical regulatory activities; advanced degree; certifications; global regulatory experience.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) (eligible employees); long-term incentive program eligibility.
Application instructions:
- None stated.