Regulatory Affairs Director

4 weeks ago

Abingdon, Oxfordshire, United Kingdom Adaptimmune Therapeutics PLC Full time
Job Title: Senior Director of Global Regulatory Affairs CMC

Adaptimmune Therapeutics PLC is a leading biotechnology company dedicated to harnessing the power of the immune system to treat cancer. We are seeking a highly experienced Senior Director of Global Regulatory Affairs CMC to lead our CMC sub-team within Global Regulatory Affairs.

Key Responsibilities:
  • Provide regulatory leadership and oversight to the CMC sub-team, ensuring the development and execution of robust CMC regulatory strategies for our product portfolio.
  • 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.
  • Actively 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 an 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.
Qualifications & Experience:
  • Bachelor's Degree in a scientific discipline is required.
  • Minimum of 10-15 years of relevant pharmaceutical/biotech experience, including minimum of 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 Therapeutics PLC is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to creating an inclusive and diverse work environment.

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