Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device
AbbVie
August 11, 2026
Remote friendly (Irvine, CA)
United States
$141,500 - $268,500 USD yearly
Corporate Functions
Responsibilities:
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or development products.
- Support Global Regulatory Lead (GRL) in developing and executing regulatory strategy for multiple indications within a Therapeutic Area.
- Lead total product lifecycle activities: change assessments, post-approval requirements, Health Authority information requests, annual reporting, and internal regulatory requests; provide business-critical guidance.
- Manage interface with FDA on key projects/issues; serve as liaison for FDA meetings/teleconferences and coordinate briefing packages and responses.
- Advise internal teams (Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Coordinate preparation and review of regulatory submissions for US/Canada, ensuring complete and timely Health Authority responses.
- Present regulatory information to cross-functional teams; act as a Regulatory SME and work in compliance with regulations, policies, procedures, and the Quality Dossier Program (QDP).
- Assist in development, training, and mentoring of junior staff.
Qualifications:
- Advanced degree (PharmD, PhD, MS) or Regulatory certification; minimum 7 years Regulatory/R&D (or equivalent industry) experience.
- Strong written and oral communication; extensive experience interfacing with Health Authorities.
- Proven negotiation, strategic thinking, and credibility; experience in complex matrix environments.
- Demonstrated implementation of affiliate regulatory strategies (US/Canada device/combination product preferred).
- US Class III device experience and knowledge of manufacturing/change control assessments preferred.
- Forward-thinking strategic experience to accelerate programs/preferably global regulatory experience (plus).
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or development products.
- Support Global Regulatory Lead (GRL) in developing and executing regulatory strategy for multiple indications within a Therapeutic Area.
- Lead total product lifecycle activities: change assessments, post-approval requirements, Health Authority information requests, annual reporting, and internal regulatory requests; provide business-critical guidance.
- Manage interface with FDA on key projects/issues; serve as liaison for FDA meetings/teleconferences and coordinate briefing packages and responses.
- Advise internal teams (Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues.
- Coordinate preparation and review of regulatory submissions for US/Canada, ensuring complete and timely Health Authority responses.
- Present regulatory information to cross-functional teams; act as a Regulatory SME and work in compliance with regulations, policies, procedures, and the Quality Dossier Program (QDP).
- Assist in development, training, and mentoring of junior staff.
Qualifications:
- Advanced degree (PharmD, PhD, MS) or Regulatory certification; minimum 7 years Regulatory/R&D (or equivalent industry) experience.
- Strong written and oral communication; extensive experience interfacing with Health Authorities.
- Proven negotiation, strategic thinking, and credibility; experience in complex matrix environments.
- Demonstrated implementation of affiliate regulatory strategies (US/Canada device/combination product preferred).
- US Class III device experience and knowledge of manufacturing/change control assessments preferred.
- Forward-thinking strategic experience to accelerate programs/preferably global regulatory experience (plus).
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.