Associate Director Global Regulatory Cmc - Cell Therapy

Retained Search

Hybrid Position

Role: As the Associate Director of Global Regulatory Affairs CMC, you will provide regulatory leadership for CMC matters related to T-cell therapies for the treatment of cancer. You will work cross-functionally with various teams, including R&D, clinical development, manufacturing, and quality assurance, to develop and execute regulatory strategies that support these therapies' development, registration, and life-cycle management.

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.

Key Responsibilities:

• Provides CMC Regulatory leadership, serving as an expert for global regulatory CMC requirements and emerging trends for cell therapy products.
• 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.
• Evaluates change proposals for global regulatory impact and plans global amendments.
• Leads interactions with FDA and other Health Authorities for CMC-related topics (including management of regulatory deliverables and commitments).
• 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 professionally and on time.
• Plans, execute, and manages regulatory CMC submissions, including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, and responses to queries.
• Ability to remain current on CMC regulatory intelligence, including guidelines and regulatory trends, and to drive and implement strategic policy decisions.

Qualifications & Experience:

• Understanding and proven ability to provide strategic guidance to drug development, registration, and post-market support teams.
• Ability to work effectively in cross-functional teams.
• Proven ability to liaise with Regulatory Agencies, having led successful Agency interactions related to CMC submissions and product development meetings; international experience preferred.
• Bachelor's Degree required; advanced Degree preferred.
• Experience with pharmaceutical development of drug substance or drug products, analytical characterization, process scale-ups, and or regulatory registration of products.
• Experience with BLAs/NDAs/MAAs.
• Knowledge of relevant domestic and global regulations and guidance.
• Provides regulatory advice, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
• Experience in Cell or Gene Therapy.
• Minimum of 10 years of pharmaceutical/biotech experience, including five years of Global Regulatory Affairs (CMC) experience.
• Experience as a RA CMC product lead.
• Proven experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs).