Director Regulatory Affairs

Lead regulatory strategy, submissions, and compliance for nuclear medicine products, focusing on new chemical entities and marketed product portfolios in the U.S. and North America.

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Job Requirements:

• BS degree in Chemistry, Pharmacy, Biology, or other life science

• 15+ years of experience in Regulatory Affairs within the pharmaceutical industry

• 5+ years of direct supervisory experience; matrix management experience preferred

• Experience with U.S. and international regulatory agencies and guidelines (FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

• Direct experience in regulatory submissions, strategy development, and dossier compilation for drug, biologic, and device applications

• Familiarity with Target Product Profile (TPP) development and dossier Table of Contents creation

• Experience with Chemistry Manufacturing Controls (CMC) dossier modules

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Preferred Skills:

• Experience coordinating with cross-functional global teams and regional regulatory staff

• Strong background in authoring and reviewing clinical protocols, non-clinical studies, and summary reports

• Experience leading health authority interactions, including preparation and execution of meetings

• Knowledge of regulatory pathways for both clinical-stage and marketed products

• Experience working with third-party service providers in the nuclear medicine sector

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Job Responsibilities:

• Manage regulatory submissions and projects, ensuring full compliance and timely execution

• Author and review regulatory content, define TPPs, and construct approvable dossiers for drug and device products

• Lead strategy, compilation, and submission for new product applications and support approvals from regulatory bodies

• Oversee U.S. regulatory activities, including coordination with Health Canada for North American compliance

• Serve as liaison with external vendors and internal stakeholders supporting nuclear medicine regulatory initiatives

• Communicate changes in regulatory policies and propose implementation strategies

• Present regulatory progress and risk assessments to executive management

• Maintain operational compliance with evolving global regulatory standards

• Manage post-approval commitments and support product launch activities

• Lead the CMC dossier modules, focusing on regulatory deliverables for chemistry-related content

Pay Details: $152,000.00 to $165,000.00 per year

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance