What are the responsibilities and job description for the Senior Director Regulatory Affairs position at Kaye/Bassman International?
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