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Director (or) Senior Director Regulatory Affairs
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What they do
A Regulatory Affairs Manager plans, directs, or coordinates production activities of an organization to ensure compliance with regulations and standard operating procedures.
$204,654 / year median in New Jersey
-0% projected decline
Job Description
Director (or) Senior Director Regulatory Affairs at Kaye/Bassman International Director (or) Senior Director Regulatory Affairs at Kaye/Bassman International in Pine Brook, New Jersey Posted in about 12 hours ago.
Type:
full-time 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 Responsibilitie s : 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