People Matter

Director, Regulatory CMC

Editas Medicine

Editas Medicine

Cambridge, MA, USA
Posted on Tuesday, April 23, 2024

At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.

We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.

Together, we are leading the way towards a healthier and more equitable future.

Position Summary

This role will lead and support the CMC strategies and submission including clinical trials applications, marketing applications, agency briefing packages and response to regulatory authority queries. The Director will incorporate regulatory strategy and well positioned content into high quality submissions to support successful outcomes. The individual will work extensively with cross-functional teams in the execution of these submissions.

Key Responsibilities:

  • As the Director, Regulatory CMC, you will be responsible for:
  • Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are informed of developments opportunities and risks that may impact regulatory success.
  • Accountable for CMC regulatory strategy for assigned portfolio programs, including but not limited to developing regulatory strategy and plan for CMC development, assessing regulatory scenarios risks and opportunities, proposing risk mitigation measures, and, assessing the probability of regulatory success, and proposing risk mitigation measures.
  • Serve as a Regulatory CMC lead on relevant cross-functional or functional teams to provide regulatory guidance and support for CMC development and ensure compliance with applicable EMA/FDA/ICH/WHO/Global regulations and regulatory guidance and guidelines.
  • Lead CMC related interactions with the health authorities including but not limited to planning for the related activities, managing preparation of meeting requests and briefing documents and contingency plan, preparing responses to preliminary comments, and leading discussions at the CMC focus health authority meetings.
  • Accountable for the management and delivery of all CMC regulatory milestones, including global investigational drug filings (e.g., IND / CTA / IMPD / GMO), registrational filings (e.g., BLA, NDS, MAA, and supplements), and responses to health authority questions/requests.
  • Responsible for establishing CMC content (data and documentation) requirements for regulatory submissions and reviewing content for conformance with established requirements.
  • Evaluate change proposals for regulatory impact and filing requirements.