Regulatory Strategy Lead, US & Canada – Facial Aesthetics Devices

AbbVie; Irvine (CA); On-site; USD 141,500 - 268,500; Full time

Job summary

AbbVie in Irvine, CA is seeking an Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device to drive regulatory strategy for both on-market and development programs across the US and Canada.

This full-time role requires leading regulatory submissions, coordinating with the FDA, and guiding cross-functional teams to ensure compliant, timely product approvals and lifecycle management.

Qualifications

• Advanced degree required with minimum 7 years regulatory, R&D, or equivalent industry experience.
• Experience leading regulatory strategy for US and Canada device products or combinations at the regulatory lead level.
• Proven ability to interface with Health Authorities (FDA) and manage cross-functional teams.

Responsibilities

• Develop and implement US/Canada regulatory strategy and tactical planning for facial aesthetics devices.
• Lead regulatory submissions and liaise with Health Authorities, including FDA meetings and briefing packages.
• Mentor junior staff and coordinate with Global Regulatory Lead and GRPT to align regulatory strategy with business goals.
• Drive lifecycle activities, including post-approval commitments, change assessments, and regulatory responses.

Skills

Regulatory strategy

FDA interactions

Cross-functional collaboration

Leadership

Negotiation

Strategic thinking

Education

Advanced degree (PharmD, PhD, MS)

Job description

AbbVie in Irvine, CA is seeking an Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device to drive regulatory strategy for both on-market and development programs across the US and Canada.

This full-time role requires leading regulatory submissions, coordinating with the FDA, and guiding cross-functional teams to ensure compliant, timely product approvals and lifecycle management.