Associate Director, Regulatory Affairs, Global Regulatory Strategy
1 NW Old State Capitol Plaza
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The Associate Director, Regulatory Affairs, Global Regulatory Strategy, US and Canada has primary responsibility 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. These responsibilities are carried out in collaboration with key internal stakeholders from within Regulatory Affairs including those on the Global Regulatory Project Team (GRPT) (i.e., CMC Regulatory, Labeling, Advertising and Promotion), ABBV Canada Affiliate Regulatory Team, and cross functional colleagues (e.g. Clinical Development, Commercial, Marketing, Product Safety), on the Integrated Brand Team. 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.
Key Responsibilities Include:
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 & execution of the regulatory strategy
Represents US/C Global Regulatory Strategy on the Integrated Brand Team
Serves as US and Canada (US/C) Regulatory Lead on the Global Regulatory Product Team (GRPT)
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
Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization
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
Able to deliver challenging messages effectively without compromising important business relationships
Establishes solid relationships with management and key stakeholders fostering mutually beneficial interactions
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
Encourages innovation and holds employees accountable for delivering on their goals; recognizes, mentors, rewards and recommends promotion for staff members based on their performance, results, and development
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
Uses problem solving skills to separate and combine tasks into efficient workflow and effectively/creatively solve complex and difficult problems
Presents pertinent regulatory information to appropriate cross-functional areas.
Provides input into the budget, identifies and communicates budgetary needs, and identifies current and future expenditures and business needs
Provide budgetary input into the use of contractors and consultants.
Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP)
Bachelor's Degree (pharmacy, biology, pharmacology) or related life sciences
Relevant advanced degree is preferred
Certification a plus
8 years Regulatory, R&D or Industry-related experience
5 years in pharmaceutical regulatory affairs
Extensive experience interfacing with government Agencies and Health Authority personnel.
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
Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus