Associate Director, Regulatory Affairs Us/Canada Area

Purpose: 

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 GRPT, are effectively implemented and maintained in line with changing regulatory and business needs.

Responsibilities: 

• This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director), in the development and execution of the regulatory strategy. Area of responsibility has significant regulatory impact and possibly significant impact to ABBV overall.
• 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. Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Operates independently, with recognition of when to consult management. Makes decisions and plans for operations (work flow, assignments, staff development) within area of responsibility with minimal direction). Assists in the development, training, and mentoring of 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 and leads the department as a subject matter expert (SME) for Regulatory.
• Presents pertinent regulatory information to appropriate cross-functional areas. Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications: 

• Required Education: Bachelor's Degree (pharmacy, biology, pharmacology) or related life sciences.
• Preferred Education: Relevant advanced degree is preferred Certification a plus
• Required Experience: 8 years Regulatory, R&D or Industry-related experience
• Preferred Experience: 5 years in pharmaceutical Regulatory Affairs.
• Skill Set: Demonstrates 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.
• Skill Set cont'd Experience working in a complex and matrix environment. Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization. Strong communication skills, both oral and written.
• Skill Set cont'd: Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus.