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

Responsibilities:
- Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market or in-development products.
- Support Global Regulatory Lead (GRL) in developing and executing regulatory strategy for products/indications within a Therapeutic Area.
- Lead total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, Health Authority information requests, annual reporting, and internal regulatory requests.
- Manage interface with Health Authority (FDA) for key projects/issues; collaborate with review division personnel; coordinate FDA meeting briefing packages and responses.
- Advise internal partners (e.g., Public Affairs, Clinical Development, Legal, Commercial) on Regulatory/FDA issues affecting regulated communications.
- Coordinate, prepare and/or supervise regulatory submissions and ensure complete, timely responses to Health Authorities.
- Apply US/Canada regulatory policies and best-practice standards for product registrations and align work with regulatory product strategy and the Quality Dossier Program (QDP).
- Present pertinent regulatory information to cross-functional teams.

Qualifications:
- Advanced degree (PharmD, PhD, MS) or Regulatory certification.
- 5+ years Regulatory, R&D, or equivalent industry experience.
- Experience in medical device space.
- Experience with digital health/software.
- Proven skill implementing affiliate regulatory strategies (US/Canada preferred).
- Experience in complex, matrix environments.
- Experience interfacing with government regulatory agencies.

Preferred:
- Global regulatory experience.
- Direct experience with pharmaceutical regulatory activities.

Other required skills:
- Negotiation, problem-solving, and consensus-building.
- Effective written and oral communication across the organization.
- Ability to deliver challenging messages without harming business relationships.