Associate Director/Director, Regulatory Affairs

Editas Medicine, Inc. Cambridge , MA 02138

Posted 2 months ago

What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We're focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases.

We're looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before.

Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities

  • Develop and implement global regulatory strategy for the company's gene editing programs

  • Represent the regulatory function on cross-functional product development teams. Provides innovative strategic and tactical advice to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.

  • Plan, prepare, and manage global submissions to regulatory authorities including INDs, CTAs, and registrational dossiers

  • Lead regulatory interactions with health authorities including managing preparation of briefing documents

  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs and senior management, as relevant.

  • Ensure that regulatory documents are accurate, complete and verifiable to confirm compliance with regulatory requirements

  • Keep abreast of relevant global regulatory requirements and keep the company informed of changes and consequences

  • Oversee vendor responsibility for regulatory activities and submissions as needed.

  • Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10+ years' experience in drug development/regulatory affairs.

  • Experience with both US FDA and EMA is required. Global experience is preferred.

  • Prior BLA and NDA experience is preferred.

  • Experience with the regulation of biologics is essential; experience with gene editing and/or cell and gene therapy preferred

  • A broad understanding of the drug product development process is required.

  • This position requires a thorough knowledge of U.S. Federal Regulations, ICH Guidances, and relevant FDA and EMA guidances

  • Proven experience in critically reviewing detailed scientific information and providing assessment of technical arguments and conclusions based on the data

  • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.

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Associate Director/Director, Regulatory Affairs

Editas Medicine, Inc.