Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada - Immunology (Hybrid)
AbbVie
August 10, 2026
Remote friendly (Irvine, CA)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
Responsibilities:
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Ensure GRPT 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.
- Support the development and execution of regulatory strategy for product(s) with multiple driver indications within a Therapeutic Area.
- Serve as HA liaison and interface with FDA for meetings/teleconferences; coordinate 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 cross-functional decisions for project-related issues.
- Assist in development and training of staff.
- Prepare and review regulatory submissions; ensure complete and timely responses to Health Authorities during review.
- Support regulatory submission and approval process.
- Recommend and implement changes to difficult projects based on interpretation of US/Canada regulations/guidances and corporate policies.
- Present relevant regulatory information to cross-functional areas.
- Operate in compliance with regulations, policies, and the Quality Dossier Program (QDP).
Qualifications:
Minimum:
- Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
- 6 years Regulatory, R&D, or Industry-related experience
- Experience in complex matrix environment
- Experience interfacing with government regulatory agencies
Preferred:
- 2-3 years pharmaceutical regulatory activities
- Global regulatory experience (plus)
- Advanced degree (plus)
- Certifications (plus)
Required 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 business relationships
- Proven experience implementing successful US and Canada regulatory strategies
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees)
- Long-term incentive programs eligibility
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Ensure GRPT 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.
- Support the development and execution of regulatory strategy for product(s) with multiple driver indications within a Therapeutic Area.
- Serve as HA liaison and interface with FDA for meetings/teleconferences; coordinate 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 cross-functional decisions for project-related issues.
- Assist in development and training of staff.
- Prepare and review regulatory submissions; ensure complete and timely responses to Health Authorities during review.
- Support regulatory submission and approval process.
- Recommend and implement changes to difficult projects based on interpretation of US/Canada regulations/guidances and corporate policies.
- Present relevant regulatory information to cross-functional areas.
- Operate in compliance with regulations, policies, and the Quality Dossier Program (QDP).
Qualifications:
Minimum:
- Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
- 6 years Regulatory, R&D, or Industry-related experience
- Experience in complex matrix environment
- Experience interfacing with government regulatory agencies
Preferred:
- 2-3 years pharmaceutical regulatory activities
- Global regulatory experience (plus)
- Advanced degree (plus)
- Certifications (plus)
Required 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 business relationships
- Proven experience implementing successful US and Canada regulatory strategies
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) (eligible employees)
- Long-term incentive programs eligibility