Senior Director of Global Regulatory Affairs CMC

4 days ago

Philadelphia, Pennsylvania, United States Adaptimmune Full time
Job Title: Senior Director of Global Regulatory Affairs CMC

Adaptimmune is a pioneering cell therapy company that is revolutionizing the treatment of cancer. We are seeking a highly experienced Senior Director of Global Regulatory Affairs CMC to lead our regulatory affairs team and ensure the successful development and approval of our cell and gene therapy products.

Key Responsibilities:
  • Provide regulatory leadership and oversight to the CMC sub-team within Global Regulatory Affairs
  • 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 the scientific/technical requirements for CMC and CGMP related submissions
  • Review and/or approve CMC and CGMP related submission documents to assure compliance with regulatory standards and scientific/technical requirements and ensure their appropriateness for use in regulatory submissions
  • Perform risk assessments for determination of probability of success for strategic regulatory CMC decisions, advise appropriate level of risk and mitigations to senior management for significant issues, as required
  • Develop and maintain collaborative relationships with internal and external stakeholders
  • Actively engage with industry organizations (eg: ARM, DIA, RAPS, etc) to drive cross-industry best practices and support evolving global regulatory CMC guidance
  • Drive adherence at enterprise level to CMC regulatory requirements and guidelines
  • Perform CMC regulatory intelligence activities - monitor regulation changes and competitor trends/strategy; Analyze trends and evaluate the impact of changes in Regulatory requirements for CMC related submissions; communicate changes to appropriate areas to ensure compliance with required standards
  • Represent the company at appropriate 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 (including management of regulatory deliverables and commitments)
  • Oversee change controls assessments and provide assessment of regulatory impact and plans global amendments
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, making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
  • Experience with filing and maintenance of regulatory dossiers (CTAs, INDs, IMPDs, BLAs/MAAs)
  • Ability to effectively 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 and matrixed teams
  • Proven leadership and management experience of regulatory staff
  • Extensive knowledge in ICH, FDA, EMA and international regulations/guidelines
Desirable:
  • Advanced degree in scientific discipline is strongly preferred
  • Experience with BLAs/NDAs/MAAs is strongly preferred
Other Requirements:
  • Travel as required for internal and external meetings, including health authority meetings

At Adaptimmune, we are committed to diversity and equality of opportunity. We welcome 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.

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