Head of Regulatory Affairs

2 months ago


Massachusetts, United States EPM Scientific Full time

Director of Regulatory Affairs

EPM Scientific is seeking a highly skilled Director of Regulatory Affairs to lead our innovative initiatives in the field of gene therapy. This role is essential in guiding our transformative projects through the intricate regulatory environment with expertise and foresight.

In this critical position, you will leverage your strategic insight and practical experience to navigate regulatory frameworks and spearhead essential submission processes. This is a unique opportunity for a driven and results-oriented leader who excels in a collaborative and diverse setting. Your contributions will be vital in propelling our cutting-edge therapies to market, as you design effective regulatory strategies and ensure smooth communication with health authorities worldwide.

Key Responsibilities:

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

Qualifications:

  • A Bachelor’s degree in a relevant life sciences discipline with a minimum of 8 years of experience in the biopharmaceutical sector, particularly in biologics and regulatory affairs.
  • Experience with gene or cell-based therapies, RNA therapeutics, or orphan drug development is highly desirable.
  • A proven history of successful BLA or MAA submissions and comprehensive knowledge of global regulatory authorities and submission processes.
  • Exceptional communication abilities, strategic leadership skills, and a dedication to high-quality, detail-oriented work.


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