Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)
AbbVie
August 10, 2026
Remote friendly (South San Francisco, CA)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) 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.
Responsibilities:
- Support the development and execution of regulatory strategy for assigned products/therapeutic areas (multiple driver indications).
- Serve as HA liaison; interface with FDA for meetings/teleconferences and coordinate FDA briefing packages and responses.
- Advise internal customers on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiate and make cross-functional decisions for project-related issues.
- Assist in development and training of staff.
- Prepare and review regulatory submissions and ensure complete, timely Health Authority responses.
- Support regulatory submission and approval process.
- Apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes for complex projects based on US/Canada regulations, guidance, and corporate policies.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations and company guidance aligned with 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 Qualifications:
- 2–3 years in pharmaceutical regulatory activities.
- Global regulatory experience (plus).
- Advanced degree (plus).
- Certifications (plus).
Other Required Skills:
- Excellent negotiation and problem-solving skills; builds consensus.
- Effective written and oral communication across and within Regulatory.
- Ability to deliver challenging messages without harming business relationships.
- Proven ability to implement successful US and Canada regulatory strategies.
Benefits (explicitly listed):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for long-term incentive programs.
Responsibilities:
- Support the development and execution of regulatory strategy for assigned products/therapeutic areas (multiple driver indications).
- Serve as HA liaison; interface with FDA for meetings/teleconferences and coordinate FDA briefing packages and responses.
- Advise internal customers on Regulatory/FDA issues (e.g., Public Affairs, Clinical Development, Legal, Commercial).
- Independently negotiate and make cross-functional decisions for project-related issues.
- Assist in development and training of staff.
- Prepare and review regulatory submissions and ensure complete, timely Health Authority responses.
- Support regulatory submission and approval process.
- Apply regulatory/technical knowledge across therapeutic areas.
- Recommend and implement changes for complex projects based on US/Canada regulations, guidance, and corporate policies.
- Present pertinent regulatory information to cross-functional areas.
- Operate in compliance with regulations and company guidance aligned with 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 Qualifications:
- 2–3 years in pharmaceutical regulatory activities.
- Global regulatory experience (plus).
- Advanced degree (plus).
- Certifications (plus).
Other Required Skills:
- Excellent negotiation and problem-solving skills; builds consensus.
- Effective written and oral communication across and within Regulatory.
- Ability to deliver challenging messages without harming business relationships.
- Proven ability to implement successful US and Canada regulatory strategies.
Benefits (explicitly listed):
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for long-term incentive programs.