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

AbbVie•North Chicago, IL

2d•$124,500 - $236,500•Hybrid

About The Position

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Requirements

Advanced degree (e.g. 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 at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
Experience working in a complex and matrix environment.
Experience interfacing with government regulatory agencies.
Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
Able to deliver challenging messages effectively without compromising important business relationships.

Nice To Haves

Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
Global regulatory experience is a plus.

Responsibilities

Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel. May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
Operates independently, with recognition of when to consult management. Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review. Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
Presents pertinent regulatory information to appropriate cross-functional teams.
Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).