Senior Manager RA, Global Reg Strategy US & Canada
AbbVie
June 26, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
Senior Manager RA, Global Reg Strategy US & Canada
Responsibilities:
- Develop and implement US & Canada regulatory strategic and tactical planning (RSTP) for assigned products (on market or in development), ensuring GRPT regulatory strategies are maintained with changing regulatory/business needs.
- Gather data to support filings, responses to inquiries, and registration maintenance to meet US/Canada regulatory requirements.
- Serve as HA liaison; coordinate FDA meetings (briefing packages and responses) and advise internal teams on Regulatory/FDA issues.
- Independently negotiate and make project decisions with cross-functional impact; assist in staff training.
- Prepare/review regulatory submissions and ensure complete, timely Health Authority responses during review.
- Support submission/approval process; apply regulatory/technical knowledge across therapeutic areas.
- Recommend/implement changes for complex projects based on regulations/guidances, corporate policies, and management considerations.
- Present regulatory information to cross-functional areas and operate in compliance with regulations, company guidance, and Quality Dossier Program (QDP).
- Significant work activity: continuous sitting >2 hours in an 8-hour day.
Qualifications:
- Required education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
- Preferred education: advanced degree; certifications.
- Required experience: 6 years Regulatory, R&D, or industry-related; plus 2–3 additional years in pharmaceutical regulatory activities (preferred).
- Skills: negotiation, problem solving, consensus building; strong written/oral communication; deliver challenging messages without harming relationships.
- Experience: implementing US/Canada regulatory strategies; complex/matrix environment; interfacing with government agencies (global regulatory experience is a plus).
Benefits (as stated): paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.
Responsibilities:
- Develop and implement US & Canada regulatory strategic and tactical planning (RSTP) for assigned products (on market or in development), ensuring GRPT regulatory strategies are maintained with changing regulatory/business needs.
- Gather data to support filings, responses to inquiries, and registration maintenance to meet US/Canada regulatory requirements.
- Serve as HA liaison; coordinate FDA meetings (briefing packages and responses) and advise internal teams on Regulatory/FDA issues.
- Independently negotiate and make project decisions with cross-functional impact; assist in staff training.
- Prepare/review regulatory submissions and ensure complete, timely Health Authority responses during review.
- Support submission/approval process; apply regulatory/technical knowledge across therapeutic areas.
- Recommend/implement changes for complex projects based on regulations/guidances, corporate policies, and management considerations.
- Present regulatory information to cross-functional areas and operate in compliance with regulations, company guidance, and Quality Dossier Program (QDP).
- Significant work activity: continuous sitting >2 hours in an 8-hour day.
Qualifications:
- Required education: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology) or industry related.
- Preferred education: advanced degree; certifications.
- Required experience: 6 years Regulatory, R&D, or industry-related; plus 2–3 additional years in pharmaceutical regulatory activities (preferred).
- Skills: negotiation, problem solving, consensus building; strong written/oral communication; deliver challenging messages without harming relationships.
- Experience: implementing US/Canada regulatory strategies; complex/matrix environment; interfacing with government agencies (global regulatory experience is a plus).
Benefits (as stated): paid time off; medical/dental/vision insurance; 401(k); long-term incentive program eligibility.