Senior Director Regulatory Affairs

I am leading a search for a Director (or) Senior Director, Global Regulatory Clinical Strategy at a commercial-stage biopharmaceutical organization focused on non-opioid pain management and regenerative health solutions, with a robust pipeline spanning small molecules, biologics, and gene therapy.

This is a highly visible leadership role overseeing the development and execution of global regulatory strategies across multiple clinical and non-clinical development programs.

Key Responsibilities:

• Lead regulatory strategy from early development through post-marketing activities
• Guide complex FDA and Health Authority interactions
• Lead the development of regulatory strategy for multiple and/or complex projects (from first-in-human to post-marketing application stage) outlined in Global
• Partner closely with Clinical Development, Nonclinical, CMC, Commercial, and Executive Leadership teams
• Provide strategic regulatory guidance across IND-enabling and clinical development programs
• Analyze and address complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and regulatory leadership
• Influence regulatory policy, intelligence, and development strategy across multiple programs
• Help build scalable regulatory processes and mentor future regulatory leaders

What We're Looking For:

• 10-15 years of progressive Regulatory Affairs experience within the pharmaceutical or biotech industry
• Deep expertise in clinical and nonclinical regulatory strategy
• Strong experience leading complex regulatory submissions and Health Authority interactions
• Scientific fluency across drug development and regulatory decision-making
• Proven ability to influence cross-functional teams and executive stakeholders
• Experience supporting early-stage innovative development programs

Why Consider This Opportunity?

• Commercial-stage organization with marketed products and a growing pipeline
• Exposure to innovative programs across biologics and gene therapy
• Significant influence on development and regulatory strategy
• High visibility with executive leadership
• Opportunity to shape and scale the Regulatory Affairs function