Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)
AbbVie
August 11, 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 products or products in development.
- Support the Global Regulatory Lead (GRL) in development and execution of regulatory strategy for products/indications within a Therapeutic Area.
- Lead total product lifecycle activities: product/manufacturing change assessments, post-approval requirements, Health Authority information requests, annual reporting, and internal regulatory requests.
- Manage interfaces with FDA for key projects/issues, collaborating with review division personnel; serve as primary liaison for FDA meetings/teleconferences and coordinate briefing packages and responses.
- Advise internal customers on Regulatory/FDA issues across Public Affairs, Clinical Development, Legal, and Commercial.
- Coordinate, prepare, and/or supervise regulatory submissions for US/Canada requirements; ensure complete and timely Health Authority responses and adherence to established policies and best practices.
- Present pertinent regulatory information to cross-functional teams.
- Operate in compliance with regulations, company policies/procedures, regulatory product strategy, and the Quality Dossier Program (QDP).
Qualifications:
- Advanced degree (PharmD, PhD, MS) or Regulatory certification.
- 5+ years Regulatory, R&D, or equivalent industry-related experience.
- Experience in medical device space.
- Experience with digital health/software.
- Proven skill implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience working in a complex, matrix environment.
- Experience interfacing with government regulatory agencies.
Preferred Qualifications:
- Advanced degree/certifications or direct experience with pharmaceutical regulatory activities.
- Global regulatory experience.
Required Skills:
- Excellent negotiation and problem-solving; builds consensus.
- Effective written and oral communication within Regulatory and across the organization.
- Delivers challenging messages while maintaining business relationships.
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market products or products in development.
- Support the Global Regulatory Lead (GRL) in development and execution of regulatory strategy for products/indications within a Therapeutic Area.
- Lead total product lifecycle activities: product/manufacturing change assessments, post-approval requirements, Health Authority information requests, annual reporting, and internal regulatory requests.
- Manage interfaces with FDA for key projects/issues, collaborating with review division personnel; serve as primary liaison for FDA meetings/teleconferences and coordinate briefing packages and responses.
- Advise internal customers on Regulatory/FDA issues across Public Affairs, Clinical Development, Legal, and Commercial.
- Coordinate, prepare, and/or supervise regulatory submissions for US/Canada requirements; ensure complete and timely Health Authority responses and adherence to established policies and best practices.
- Present pertinent regulatory information to cross-functional teams.
- Operate in compliance with regulations, company policies/procedures, regulatory product strategy, and the Quality Dossier Program (QDP).
Qualifications:
- Advanced degree (PharmD, PhD, MS) or Regulatory certification.
- 5+ years Regulatory, R&D, or equivalent industry-related experience.
- Experience in medical device space.
- Experience with digital health/software.
- Proven skill implementing successful affiliate regulatory strategies (US or Canada experience preferred).
- Experience working in a complex, matrix environment.
- Experience interfacing with government regulatory agencies.
Preferred Qualifications:
- Advanced degree/certifications or direct experience with pharmaceutical regulatory activities.
- Global regulatory experience.
Required Skills:
- Excellent negotiation and problem-solving; builds consensus.
- Effective written and oral communication within Regulatory and across the organization.
- Delivers challenging messages while maintaining business relationships.