Head of Regulatory Affairs

2 months ago


Massachusetts, United States EPM Scientific Full time

Director of Regulatory Affairs

EPM Scientific is seeking a visionary Director of Regulatory Affairs to lead our innovative projects in the gene therapy sector. This pivotal position requires a strategic thinker with a robust understanding of the regulatory landscape, dedicated to guiding our groundbreaking initiatives through complex regulatory processes.

In this influential role, you will leverage your expertise to navigate regulatory frameworks and spearhead essential registration activities. This is an exceptional opportunity for a proactive leader who excels in a collaborative and diverse setting. Your contributions will be vital in propelling our cutting-edge therapies to market, as you develop effective regulatory strategies and foster productive relationships 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 across teams and showcasing superior 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 the creation and review of essential documentation.
  • Collaborate closely with Nonclinical, Technical Operations, Quality Assurance, and Clinical teams to meet timelines and achieve timely 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 in gene or cell-based therapies, RNA therapeutics, or orphan drug development is highly desirable.
  • A proven history of successful BLA or MAA submissions and extensive familiarity with global regulatory authorities and submission processes.
  • Outstanding communication abilities, strategic leadership, and a commitment to meticulous, high-quality work.


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