Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)
AbbVie
August 11, 2026
Remote friendly (Branchburg, NJ)
United States
$124,500 - $236,500 USD yearly
Corporate Functions
Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device
Responsibilities:
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Support the Global Regulatory Lead (GRL) in development and execution of regulatory strategy; ensure alignment with Global Regulatory Product Team (GRPT) and changing regulatory/business needs.
- Identify and gather data to support filings, responses to inquiries, and registration maintenance for commercialization.
- Lead total product lifecycle activities (product/manufacturing change assessments, post-approval requirements, Health Authority information requests, annual reporting, and internal regulatory requests).
- Manage interface with FDA for key projects/issues, including collaboration with review division personnel; coordinate preparation of FDA meeting briefing packages and responses.
- Advise internal stakeholders (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues impacting regulated communication.
- Coordinate, prepare, and/or supervise regulatory submissions and ensure complete, timely responses during application review; apply established policies and best-practice regulatory standards for US/Canada registrations.
- Present pertinent regulatory information to cross-functional teams and operate in compliance with regulations, company policies, procedures, guidance, and the Quality Dossier Program (QDP).
Qualifications:
Minimum:
- Advanced degree (PharmD, PhD, MS) or regulatory certification
- 5+ years Regulatory, R&D, or equivalent industry experience
- Medical device experience
- Digital health/software experience
- Proven success implementing affiliate regulatory strategies (US/Canada preferred)
- Experience in complex matrix environments
- Experience interfacing with government regulatory agencies
Preferred:
- Advanced degree/certifications and/or direct pharmaceutical regulatory activities
- Global regulatory experience
Required skills:
- Excellent negotiation, problem-solving, and consensus-building
- Effective written and oral communication within Regulatory and across the organization
- Ability to deliver challenging messages while maintaining business relationships
Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k)
- Eligible for long-term incentive programs
Responsibilities:
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Support the Global Regulatory Lead (GRL) in development and execution of regulatory strategy; ensure alignment with Global Regulatory Product Team (GRPT) and changing regulatory/business needs.
- Identify and gather data to support filings, responses to inquiries, and registration maintenance for commercialization.
- Lead total product lifecycle activities (product/manufacturing change assessments, post-approval requirements, Health Authority information requests, annual reporting, and internal regulatory requests).
- Manage interface with FDA for key projects/issues, including collaboration with review division personnel; coordinate preparation of FDA meeting briefing packages and responses.
- Advise internal stakeholders (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues impacting regulated communication.
- Coordinate, prepare, and/or supervise regulatory submissions and ensure complete, timely responses during application review; apply established policies and best-practice regulatory standards for US/Canada registrations.
- Present pertinent regulatory information to cross-functional teams and operate in compliance with regulations, company policies, procedures, guidance, and the Quality Dossier Program (QDP).
Qualifications:
Minimum:
- Advanced degree (PharmD, PhD, MS) or regulatory certification
- 5+ years Regulatory, R&D, or equivalent industry experience
- Medical device experience
- Digital health/software experience
- Proven success implementing affiliate regulatory strategies (US/Canada preferred)
- Experience in complex matrix environments
- Experience interfacing with government regulatory agencies
Preferred:
- Advanced degree/certifications and/or direct pharmaceutical regulatory activities
- Global regulatory experience
Required skills:
- Excellent negotiation, problem-solving, and consensus-building
- Effective written and oral communication within Regulatory and across the organization
- Ability to deliver challenging messages while maintaining business relationships
Benefits (if applicable):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k)
- Eligible for long-term incentive programs