Director, North America Regulatory Affairs Leader

Director-level regulatory affairs leader responsible for developing and executing North American regulatory strategies, managing cross-functional teams, and overseeing FDA interactions. This role ensures alignment of portfolio priorities, leads regulatory submissions, and drives compliance across Innovative Medicine products.

Responsibilities

• Establish North American content requirements and timelines for global regulatory dossiers including BLAs, NDAs, INDs, and CTAs
• Serve as primary FDA contact and lead regulatory response team for FDA and Health Canada inquiries
• Manage post-approval commitments, review and approve submission documents before dispatch to authorities
• Direct managers and individual contributors; provide career development, coaching, and regular feedback
• Develop North American labeling negotiation strategies and manage USPI development with cross-functional stakeholders

Requirements

• Bachelor's degree in scientific discipline; Advanced degree (MS, PhD, PharmD) preferred
• Minimum 10 years relevant regulatory affairs experience
• Proven experience leading health authority interactions
• Broad drug development knowledge from early through late stage and lifecycle management
• Working knowledge of US and EMA labeling requirements
• In-depth knowledge of US FDA, Health Canada, and global regulations
• Experience managing multiple-product portfolios in matrixed environments