Director, RA Global Regulatory Strategy

AbbVie seeks a Director of Global Regulatory Strategy for its neuroscience portfolio in Florham Park, NJ. This senior regulatory role involves developing and implementing global market approval strategies, leading cross-functional teams, and managing pharmaceutical products through all development phases while ensuring compliance with worldwide regulatory requirements.

Responsibilities

• Lead Global Regulatory Product Team to develop creative global strategies aligned with regulations and business objectives
• Interface with Labeling Regulatory Strategy Team and other cross-functional stakeholders on strategic messaging and dossier content
• Prepare and maintain global regulatory product strategies, risk assessments, and mitigation plans for assigned products
• Present regulatory assessments and recommendations to executive management with accountability for corporate goals
• Manage budget allocations, project resourcing, and regulatory record-keeping policies and procedures

Requirements

• Bachelor's degree in life sciences, pharmacy, biology, chemistry, or pharmacology
• 7+ years regulatory experience including US&C drug development
• 5+ years in strategic leadership role with strong project management skills
• Experience in complex matrix environments influencing cross-functional teams
• Proven ability to develop and implement global regulatory strategies
• Strong communication and proactive negotiation skills
• 10+ years pharmaceutical regulatory experience preferred; advanced degree preferred