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Senior Director, Regulatory & Clinical Strategy

Job

Kaye/Bassman International

Mountain Lakes, NJ (In Person)

Full-Time

Posted 1 week ago (Updated 1 day ago) • Actively hiring

Expires 7/20/2026

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Job Description

Senior Director, Regulatory & Clinical Strategy at Kaye/Bassman International Senior Director, Regulatory & Clinical Strategy at Kaye/Bassman International in Mountain Lakes, New Jersey Posted in 3 days ago.
Type:
full-time
Job Description:
My client is a commercial-stage biopharmaceutical organization focused on advancing innovative therapies in non-opioid pain management and regenerative health, with a pipeline spanning small molecules, biologics, and gene therapy. This highly visible leadership role will drive regulatory strategy across clinical and nonclinical development programs supporting both marketed products and pipeline assets.
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+ years of pharmaceutical Regulatory Affairs experience 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 help shape and scale the Regulatory Affairs function