Senior Director, Regulatory Affairs

Key Responsibilities

• Lead the Regulatory Affairs function across the Americas region, providing strategic direction and oversight for all regulatory activities.
• Develop and execute regulatory strategies supporting commercial products, manufacturing changes, lifecycle management activities, and business growth initiatives.
• Serve as the primary regulatory liaison with health authorities, including the FDA, Health Canada, and other applicable agencies.
• Provide strategic oversight for major regulatory submissions, including BLAs, INDs, supplements, annual reports, CMC submissions, and post-approval filings.
• Lead regulatory strategy related to manufacturing changes, facility changes, comparability assessments, labeling updates, and lifecycle management activities.
• Partner cross-functionally with Quality, Manufacturing, Medical Affairs, Pharmacovigilance, Commercial, Clinical Development, Supply Chain, Legal, and Global Regulatory teams.
• Provide regulatory leadership for inspection readiness, audit support, agency inspections, and regulatory compliance initiatives.
• Build, mentor, and develop a high-performing regulatory team while driving organizational excellence and continuous improvement.

Qualifications

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• 10+ years of progressive Regulatory Affairs experience within the pharmaceutical, biotechnology, or biologics industry.
• Prior people leadership experience with responsibility for building and managing regulatory teams.
• Strong expertise in CMC regulatory affairs, biologics regulations, cGMP requirements, and post-approval lifecycle management.
• Experience authoring and leading regulatory submissions for FDA, Health Canada, and/or international regulatory agencies.
• Proven success developing regulatory strategies supporting commercial products and manufacturing operations.
• Strong understanding of regulatory requirements impacting biologics, pharmaceuticals, and related healthcare products.
• Excellent communication, stakeholder management, and leadership skills.

*Hybrid schedule of one week per month in North Carolina.