Associate Director, RA Global Reg Strategy

Summary

Join AbbVie as an Associate Director, RA Global Regulatory Strategy, US & Canada, and lead the development and implementation of regulatory strategies for on-market and developing products. You will manage interactions with the FDA, advise internal teams, and ensure compliance with US and Canada regulations. This role requires strong communication, negotiation, and problem-solving skills, along with extensive experience in regulatory affairs. The position offers flexibility with an on-site/hybrid schedule and a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and 401(k). AbbVie is committed to diversity and inclusion and offers opportunities for professional growth.

Requirements

• Bachelor’s Degree (pharmacy, biology, pharmacology) or related life sciences
• 8 years Regulatory, R&D or Industry-related experience
• Demonstrate 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 matrix environment
• Demonstrated success in negotiation skills, strategic thinking, and credibility within the organization
• Strong communication skills, both oral and written

Responsibilities

• Develop and implement 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
• Ensure that regulatory strategies defined within the GRPT are effectively implemented and maintained
• Support the Global Regulatory Lead (GRL, Director), in the development & execution of the regulatory strategy
• 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 on Regulatory/FDA issues
• Demonstrate excellent negotiation skills, problem-solving skills and build consensus
• Operate independently, with recognition of when to consult management
• Make decisions and plans for operations (workflow, assignments, staff development) within area of responsibility with minimal direction
• Assist in the development, training, and mentoring of staff members
• Coordinate, prepare and/or supervise the preparation and review of regulatory submissions
• Ensure application of established policies and best practice regulatory standards for all US/Canada product registrations
• Demonstrate solid understanding of current US and Canada regulations and guidance, political and legal climate, and industry practices
• Broadly apply regulatory/technical knowledge across therapeutic areas and lead the department as a subject matter expert (SME) for Regulatory
• Present pertinent regulatory information to appropriate cross-functional areas
• Operate in compliance with regulations, company policies, procedures, and guidance

Preferred Qualifications

• Relevant advanced degree
• Certification
• 5 years in pharmaceutical regulatory affairs
• Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs