Regulatory CMC Manager – Contract

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in implementing regulatory CMC strategies for marketed cell and gene therapy products.

• Play a role in the planning, preparation, and submission of regulatory CMC documentation.

• Offer regulatory support and advice to various cross-functional teams.

• Plan and execute international regulatory CMC submissions, including the development of content plans.

• Review CMC sections of regulatory submissions, along with interactions and responses to regulatory agencies.

• Aid in the formulation of global regulatory CMC strategies for commercial products.

• Collaborate with regulatory and technical teams to ensure timely submission and approval of CMC changes in the post-approval setting.

• Provide regulatory CMC guidance to cross-functional teams and key stakeholders.

• Support regulatory evaluations and provide guidance on product compliance issues such as change controls, deviations, and GMP investigations.

⛳️ Requirements

• Bachelor’s degree preferred in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics, or Medical Devices, or another related life-science discipline.

• Minimum of 5 years of experience in Regulatory CMC, ideally within the biologics or cell and gene therapy sectors.

• Excellent interpersonal skills for exchanging complex information and guiding others.

• Knowledgeable in FDA, EMA, and international regulatory guidelines.

• Experienced in the preparation, review, and submission of CMC post-approval variations.

• Strong planning, strategic thinking, and problem-solving abilities.

• Capacity to collaborate and communicate openly, clearly, comprehensively, timely, and consistently.

• Aptitude for strategic thinking with the ability to navigate complex and ambiguous situations.

🏝️ Benefits

• Eligible for overtime pay in accordance with federal and state requirements.