Senior Director, Regulatory Affairs

A global biopharmaceutical company specializing in innovative therapies is seeking a Senior Director, Regulatory Affairs to lead regulatory strategy and execution across North America. This executive leadership role will oversee regulatory activities supporting commercial biologic products, manufacturing operations, lifecycle management initiatives, and future development programs while serving as a key strategic advisor to senior leadership.

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.
• Serve as a key reviewer for product labeling, promotional materials, and regulatory communications.
• 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.