Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)
AbbVie
August 10, 2026
Remote friendly (Florham Park, NJ)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or products in development.
Responsibilities:
- Own regulatory strategy and support the Manager (GRL/Associate Director/Director) for assigned products/therapeutic areas.
- Serve as HA liaison; interface with FDA for meetings/teleconferences; coordinate FDA meeting briefing packages and responses.
- Advise internal stakeholders on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiate and make cross-functional decisions.
- Assist in development and training of staff.
- Prepare and review regulatory submissions; ensure complete and timely responses to Health Authorities.
- Support regulatory submission and approval process.
- Recommend and implement changes for complex projects based on US/Canada regulations, guidances, and corporate policies.
- Present relevant regulatory information to cross-functional areas.
- Operate in compliance with regulations and company guidance aligned with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications:
- Minimum: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related); 6 years Regulatory/R&D/industry experience; experience in complex matrix environment; experience interfacing with government regulatory agencies.
- Preferred: 2–3 years pharmaceutical regulatory activities; global regulatory experience; advanced degree; certifications.
Skills:
- Excellent negotiation and problem-solving; builds consensus.
- Strong written and oral communication within Regulatory and across the organization.
- Ability to deliver challenging messages while maintaining key business relationships.
- Proven skill implementing successful US and Canada regulatory strategies.
Benefits (if applicable): Paid time off; medical/dental/vision insurance; 401(k) (eligible employees); long-term incentive eligibility.
Responsibilities:
- Own regulatory strategy and support the Manager (GRL/Associate Director/Director) for assigned products/therapeutic areas.
- Serve as HA liaison; interface with FDA for meetings/teleconferences; coordinate FDA meeting briefing packages and responses.
- Advise internal stakeholders on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiate and make cross-functional decisions.
- Assist in development and training of staff.
- Prepare and review regulatory submissions; ensure complete and timely responses to Health Authorities.
- Support regulatory submission and approval process.
- Recommend and implement changes for complex projects based on US/Canada regulations, guidances, and corporate policies.
- Present relevant regulatory information to cross-functional areas.
- Operate in compliance with regulations and company guidance aligned with regulatory product strategy and the Quality Dossier Program (QDP).
Qualifications:
- Minimum: Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related); 6 years Regulatory/R&D/industry experience; experience in complex matrix environment; experience interfacing with government regulatory agencies.
- Preferred: 2–3 years pharmaceutical regulatory activities; global regulatory experience; advanced degree; certifications.
Skills:
- Excellent negotiation and problem-solving; builds consensus.
- Strong written and oral communication within Regulatory and across the organization.
- Ability to deliver challenging messages while maintaining key business relationships.
- Proven skill implementing successful US and Canada regulatory strategies.
Benefits (if applicable): Paid time off; medical/dental/vision insurance; 401(k) (eligible employees); long-term incentive eligibility.