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).