Regulatory Affairs Director

4 weeks ago

Cambridge, Massachusetts, United States Thymmune Therapeutics Full time
Job Overview

Thymmune Therapeutics is a preclinical biotechnology company based in Cambridge, MA, applying proprietary insights in thymic engineering to develop and commercialize immune cell therapy products addressing significant opportunities with unmet clinical need across immunology.

We are seeking a highly skilled and experienced Head of Regulatory Affairs to join our team. The ideal candidate will have a successful record of approved regulatory submissions and will be responsible for leading the Regulatory Affairs function, overseeing and directing the strategic planning and execution of non-clinical, CMC, and clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization.

Key Responsibilities:

  • Set strategy, direct, plan and implement non-clinical, CMC, and clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization.
  • Interact with the FDA and other regulatory agencies to seek scientific and regulatory advice and obtain required approvals.
  • Provide strong cross-functional leadership for global filings including authoring and reviewing sections of IND, CTA, BLA, MAA, and other global submission documents in support of clinical trials and marketing applications, as well as their amendments, in conformance with local regulatory requirements.
  • Develop and implement cross-functional department policies, processes, work instructions, and standard operating procedures.
  • Provide regulatory leadership for due diligence activities and partnering activities.
  • Ensure inspection readiness efforts for regulatory activities and files.
  • Manage regulatory budgets and vendors.
  • Maintain current expertise in regulatory trends and operations.
  • Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science.

Qualifications and Experience

Required

  • Bachelor's degree required, with an advanced scientific degree (PhD, PharmD, MD) strongly preferred.
  • 15 years or more of experience (Bachelor's degree) or 10 years or more experience (PhD) leading Regulatory Affairs function and people management experience. At least 2-5 years of supervisory experience.
  • Extensive regulatory experience with clearing INDs and CTAs and gaining approvals of BLAs and MAAs.
  • Demonstrated proficiencies in leading successful health authority meetings.
  • Experience with cell therapy products and interacting with FDA CBER and EMA; additional experience with the FDA immunology division is a plus.
  • Experience in leading multidisciplinary teams.
  • Strong knowledge in clinical, CMC, and nonclinical regulatory science.
  • Experience in authoring nonclinical and CMC modules and clinical protocols for regulatory submissions.
  • Strong understanding of cGMPs.
  • Prior experience with overseeing regulatory strategy for all phases of development from pre-IND to pivotal phase and preferably commercialization.
  • Knowledgeable regarding global regulatory submission standards and publishing best practices.

Preferred

  • Excellent communication and collaboration skills across levels and functions.
  • Ability to work independently and collaboratively in a highly dynamic work environment.
  • Strong initiative, accountability, and willingness to take ownership and drive projects to completion.
  • Ability to set priorities, work independently and deliver results in a timely manner.
  • Sound strategic, technical, operational, and ethical judgment with uncompromising integrity.

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