Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device

AbbVie•Irvine, CA

23d

About The Position

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. Assures 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 has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy. Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall. 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. Provides direction and technical insight when necessary to ensure real-time guidance. Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel. May also serves as primary liaison and interfaces 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). Assists in the development, training, and mentoring of junior staff members. 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. Demonstrates solid understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals. Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas and is generally recognized as a resource & leads the department as a subject matter expert (SME) for Regulatory. 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).

Requirements

Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification with minimum 7 years Regulatory, R&D, or equivalent industry-related experience.
Effective communication skills in written and oral channels both within Regulatory and across the organization.
Extensive experience interfacing with government Agencies and Health Authority personnel.
Able to deliver challenging messages effectively without compromising important business relationships.
Experience working in a complex and matrixed environment.
Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization.
Proven skill at implementing successful affiliate regulatory strategies (US or Canada device or combination product (device primary) experience preferred).
US Class III device experience and familiarity with manufacturing processes/change control assessments is preferred.
Demonstrated, forward-thinking strategic experience to accelerate programs or establish regulatory precedence using novel approaches is a plus.
Global regulatory experience is a plus.

Nice To Haves

US Class III device experience and familiarity with manufacturing processes/change control assessments is preferred.
Demonstrated, forward-thinking strategic experience to accelerate programs or establish regulatory precedence using novel approaches is a plus.
Global regulatory experience is a plus.

Responsibilities

Development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.
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.
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.
Support the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.
Lead total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests.
Manage interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.
Serve as primary liaison and interface with FDA for meetings, teleconferences and coordinate 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.
Operate independently, with recognition of when to consult management.
Make decisions and plans for operations workflow, assignments) within area of responsibility with minimal direction).
Assist in the development, training, and mentoring of junior staff members.
Coordinate, prepare and/or supervise the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assure complete and timely response to Health Authorities during application review.
Ensure application of established policies and best practice regulatory standards for all US/Canada product registrations.
Present pertinent regulatory information to appropriate cross-functional teams.
Operate in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).