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.

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

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

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 California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance