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Associate Director/Director Regulatory Affairs, CMC

Company: TCR-- Therapeutics
Location: Cambridge
Posted on: April 10, 2021

Job Description:

Associate Director/Director Regulatory Affairs, CMC At TCR-- Therapeutics Inc, our inclusive and diverse team is passionate about curing cancer. We are a clinical-stage immunotherapy company pioneering the development of novel T cell therapies. Our two lead cell product candidates are being studied in Phase 1/2 trials: TC-210 for solid tumors and TC-110 for hematological malignancies. Our research efforts focus on broadening our pipeline with a series of next-generation enhancements that may further improve clinical outcomes. We are headquartered in Cambridge, Massachusetts and have a clinical manufacturing facility in Stevenage, UK. This role is located in Cambridge MA. We are looking for a Regulatory CMC Associate Director/Director with experience in cell/gene therapy and/or biologic. You will report to our Vice President of Regulatory Affairs and work closely with our process development, manufacturing and quality teams to serve as the product lead for CMC regulatory strategy. You will proactively manage multiple Regulatory CMC projects by coordinating with both internal and external stakeholders. You will formulate and implement global CMC regulatory strategies for the development of TRuC programs that are in line with global requirements and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs. We're looking for someone who can think strategically, partner confidently, and roll up their sleeves to get it done. If you thrive in a highly collaborative, fast-paced environment and are looking for a role where you're given ownership and accountability to get results and make an impact, we want to hear from you. Responsibilities:

  • Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for cell and gene therapy projects/products.
  • Lead and implement global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products
  • Identify the required documentation and any content, quality and/or timelines issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
  • Author and/or review high-quality CMC documentation for HA submission, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines. Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
  • Proactively communicate CMC regulatory strategies, risks and key issues throughout the life cycle in a timely manner to project teams and other stakeholders. Represent department in cross-functional project teams.
  • Regulatory assessments on change controls
  • Prepare and communicate CMC risk management assessments and lessons learned on major submissions
  • Initiate and lead Health Authority interactions and negotiations
  • Mange relationships with diverse teams Requirements:
    • Minimum BA/BS Degree with 8+ years Pharmaceutical industry experience - prefer knowledge of biotechnology / cell therapy products, including multi-disciplined experience, 5+ years CMC regulatory strategy (biologics/cell therapy experience preferred)
    • Knowledge of CMC regulatory requirements during development and post-approval. Experience with global CMC regulations for biological/cell therapy compounds preferred
    • Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods. Expertise in the cell therapy drug development process and analytical methods, preferred
    • Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multi-functional teams, handle and prioritize multiple projects and work independently
    • Ability to interpret global regulations and guidance
    • Strong oral and written skills. Ability to identify, communicate and resolve complex issues.
    • Proficient with electronic systems
    • Open to remote based candidates who can travel to Boston frequently, potentially weekly The following questions are entirely optional. To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more .

Keywords: TCR-- Therapeutics, Cambridge , Associate Director/Director Regulatory Affairs, CMC, Executive , Cambridge, Massachusetts

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