Associate Director (or) Director

Organization: My client is a growing immune-oncology company and leader in T-cell therapies focused on transforming the lives of cancer patients. They are breaking new ground with science and technology, making now a perfect time to join their incredibly collaborative and patient-focused team.

Role: The Associate Director (or) Directory Regulatory CMC will provide CMC regulatory leadership and act as the point of contact for cross-function teams to support the strategy and development of T-cell therapies for the treatment of cancer.

Key Responsibilities:

• Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
• Acts as point of contact to cross-functional teams on regulatory CMC project issues. Ensures project teams, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment, and communicating in a professional and timely manner.
• Actively collaborates with internal teams (Technical Development and Manufacturing, including Supply Chain and Quality, external partners, and CROs) to develop and execute robust CMC regulatory strategies.
• Plans execute and manage regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
• Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
• Ability to remain current on CMC regulatory intelligence, including guidelines and regulatory trends, and to drive and implement strategic policy decisions.
• Evaluate change proposals for global regulatory impact and plan global amendments.

Experience:

• Bachelor’s Degree required Advanced Degree preferred.
• Minimum of 8 years of pharmaceutical/biotech experience, including 5 years of Global Regulatory Affairs (CMC) experience.
• Experience with pharmaceutical development of drug substance or product products, analytical characterization, process scale-up, and/or regulatory registration of products.
• Understanding and proven ability to provide strategic guidance to drug development, registration, and post-market support teams. Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Proven experience with filing and maintaining regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs).
• Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency interactions related to CMC submissions and product development meetings; international experience preferred.
• Knowledge of relevant domestic and global regulations and guidance.
• Ability to work effectively in cross-functional teams.
• Willing to travel domestically and internationally up to 15%.
• Experience as a Regulatory Affairs CMC product lead is strongly preferred.
• Experience in cell and gene therapy or biologics is strongly preferred.
• Experience with BLAs/NDAs/MAAs is strongly preferred.

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