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Regulatory Affairs Director
1 month ago
Adaptimmune is a pioneering cell therapy company with a strong presence in the UK and US. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is built on trust, inclusion, collaboration, and a commitment to honesty and bravery in our pursuit of transforming lives through cancer treatment.
Key Responsibilities- Lead the CMC sub-team within Global Regulatory Affairs, providing regulatory affairs leadership and oversight in support of the product portfolio.
- Develop and execute robust CMC regulatory strategies for the Adaptimmune portfolio, including development, registration, and life-cycle management stages.
- Supervise the work of Reg CMC subteam members and manage external vendors supporting the Reg CMC activities.
- Oversee CMC regulatory staff and participate in skill-development, coaching, and performance feedback of CMC regulatory staff.
- Provide guidance on scientific/technical requirements for CMC and CGMP related submissions.
- Review and/or approve CMC and CGMP related submission documents to ensure compliance with regulatory standards and scientific/technical requirements.
- Perform risk assessments for determination of probability of success for strategic regulatory CMC decisions.
- Develop and maintain collaborative relationships with internal and external stakeholders.
- Engage with industry organizations to drive cross-industry best practices and support evolving global regulatory CMC guidance.
- Drive adherence to CMC regulatory requirements and guidelines at the enterprise level.
- Perform CMC regulatory intelligence activities, monitoring regulation changes and competitor trends/strategy.
- Represent the company at regulatory and scientific conferences.
- Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities.
- Direct the authoring, review, and finalization of CMC Regulatory documentation.
- Lead interactions with FDA and other Health Authorities for CMC-related topics.
- Bachelor's Degree in a scientific discipline is required.
- Minimum of 10-15 years of relevant pharmaceutical/biotech experience, including 5 years of Global Regulatory Affairs CMC experience in the cell and gene therapy space.
- Experience with pharmaceutical development of drug substance and drug products, including analytical characterization and manufacturing process development.
- Proven understanding and ability to provide regulatory strategic guidance to drug development, registration, and post-market support teams.
- Successful track record of providing robust regulatory advice and making reasoned decisions on regulatory issues.
- Experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs).
- Ability to effectively liaise with Regulatory Agencies and participate in successful Agency interactions related to CMC submissions and product development meetings.
- Knowledge of relevant domestic and global regulations and guidance.
- Ability to work effectively in cross-functional and matrixed teams.
- Proven leadership and management experience of regulatory staff.
- Extensive knowledge in ICH, FDA, EMA, and international regulations/guidelines.
Adaptimmune is an equal opportunities employer and welcomes applications 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.
