Head of Regulatory Affairs

1 week ago


Massachusetts, United States EPM Scientific Full time

Director, Regulatory Affairs

This position is with an innovative company at the forefront of gene editing, dedicated to advancing therapies in gene technology and more. We are in search of a skilled Director of Regulatory Affairs to guide our transformative initiatives through the intricate regulatory environment with clarity and expertise.

In this essential role, you will leverage your strategic insight and practical experience to address regulatory challenges and lead vital submission processes. This is a unique opportunity for a forward-thinking and results-oriented professional who excels in a collaborative and diverse setting. Your contributions will be crucial in propelling our pioneering therapies to market, as you design effective regulatory strategies and facilitate smooth communications with health authorities worldwide.

Key Responsibilities:

  • Address intricate scientific challenges and align them with regulatory strategies to create successful pathways.
  • Oversee the preparation and submission of comprehensive regulatory documents and clinical trial applications, working collaboratively and showcasing exceptional writing skills.
  • Act as the primary point of contact with international health authorities, ensuring clear and proactive communication to meet project objectives.
  • Ensure adherence to global regulatory standards for gene therapy products, including the drafting and review of essential documentation.
  • Collaborate closely with Nonclinical, Technical Operations, Quality Assurance, and Clinical teams to meet timelines and secure prompt approvals.

Qualifications:

  • Bachelor's degree in a relevant life sciences discipline with a minimum of 8 years of experience in the biopharmaceutical sector, specifically in biologics and regulatory affairs.
  • Experience in gene or cell-based therapies, RNA therapeutics, or orphan drug development is highly advantageous.
  • Demonstrated success with BLA or MAA submissions and extensive familiarity with global regulatory agencies and submission categories.
  • Outstanding communication abilities, strategic leadership, and a dedication to high-quality, detail-oriented work.


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