Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device (Hybrid)

AbbVie•Irvine, CA

4d•$124,500 - $236,500•Hybrid

About The Position

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead is responsible for developing and implementing US and Canada regulatory strategic and tactical plans for assigned marketed products or products in development. The role combines scientific, regulatory, and business knowledge to support product development and commercialization in accordance with applicable US and Canadian requirements. The position ensures strategies established within the Global Regulatory Product Team are implemented and maintained as regulatory and business needs evolve, and identifies and gathers data for filings, inquiry responses, and registration maintenance. The role supports the Global Regulatory Lead in developing and executing regulatory strategy for products or multiple driver indications within a therapeutic area. It leads total product lifecycle activities, including change assessments, post-approval requirements, Health Authority information requests, annual reporting, and internal regulatory requests. The Senior Manager coordinates and reviews regulatory submissions, supports timely and complete responses to Health Authorities, and advises cross-functional partners on regulatory matters. The position operates independently within its area of responsibility while consulting management as needed.

Requirements

Advanced degree (e.g., PharmD, PhD, or MS) or regulatory certification.
At least 5 years of Regulatory, R&D, or equivalent industry-related experience.
Experience in the medical device space.
Experience with digital health or software.
Demonstrated ability to implement successful affiliate regulatory strategies; US or Canada experience preferred.
Experience working in a complex, matrixed environment.
Experience interfacing with government regulatory agencies.
Excellent negotiation and problem-solving skills, with the ability to build consensus.
Effective written and oral communication skills within Regulatory and across the organization.
Ability to deliver challenging messages effectively while maintaining important business relationships.

Nice To Haves

Advanced degree and/or certifications, or direct experience with pharmaceutical regulatory activities.
Global regulatory experience.

Responsibilities

Develop and implement US and Canada regulatory strategic and tactical plans for assigned marketed products or products in development.
Support the Global Regulatory Lead in developing and executing regulatory strategy for products or multiple driver indications within a therapeutic area.
Lead product lifecycle activities, including product and manufacturing change assessments, post-approval requirements, Health Authority information requests, annual reporting, and internal regulatory requests.
Manage interactions with the FDA for key projects and issues, including collaboration with review division personnel; serve as primary FDA liaison when appropriate.
Coordinate FDA meetings and teleconferences and prepare FDA meeting briefing packages and responses.
Advise internal stakeholders, including Public Affairs, Clinical Development, Legal, and Commercial, on Regulatory and FDA issues relevant to regulated communications.
Plan and make operational decisions, including workflow and assignments, within the area of responsibility, with minimal direction and appropriate consultation with management.
Coordinate, prepare, supervise, and review regulatory submissions in accordance with US and Canadian requirements and guidelines; ensure timely and complete responses to Health Authorities during application review.
Ensure established policies and regulatory best practices are applied to US and Canada product registrations.
Apply knowledge of US and Canadian regulations, guidance, political and legal climate, and industry practices to support organizational goals.
Present relevant regulatory information to cross-functional teams.
Operate in compliance with regulations, company policies, procedures, guidance, regulatory product strategy, and the Quality Dossier Program.