Associate Director, Global Regulatory Affairs - CMC (hybrid)

Full Time On-Site/Hybrid Regulatory Affairs Director Regulatory Affairs Apply for this Job Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.

We are seeking a highly motivated and experienced individual for an Associate Director position in global Regulatory Affairs CMC. This position will provide CMC regulatory leadership and act as the point of contact on cross-function teams to support the strategy and development of our 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 judgement 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, executes, and manages regulatory CMC submissions including BLA/MAA, INDs, CTAs/IMPDs, briefing documents, 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.
• Evaluates change proposals for global regulatory impact and plans global amendments.

Qualifications & Experience

• Bachelor’s Degree required; advanced degree preferred.
• Minimum of 8 years of pharmaceutical/biotech experience including 5 year of Global Regulatory Affairs (CMC) experience
• Experience with pharmaceutical development of drug substance or drug products, analytical characterization, process scale-ups 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 maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs)
• Proven ability to liase 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.

Desirable

• Experience as a RA CMC product lead strongly preferred.
• Experience in cell and gene therapy or biologics is strongly preferred.
• Experience with BLAs/NDAs/MAAs strongly preferred.

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.