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Regulatory Affairs Director

2 months ago

Reston, Virginia, United States EPM Scientific Full time

Director, Regulatory Strategy

We are seeking a visionary Director of Regulatory Strategy to drive our groundbreaking gene editing projects through the complex regulatory landscape with precision and expertise.

In this pivotal role, you'll harness your strategic acumen and hands-on expertise to navigate regulatory requirements and lead critical registration efforts. This is an unparalleled opportunity for a proactive and results-driven leader who thrives in a collaborative, diverse environment.

Key Responsibilities:

  • Develop and execute regulatory strategies to ensure seamless interactions with global health authorities and advance our innovative therapies to market.
  • Lead the preparation and submission of high-quality regulatory dossiers and clinical trial applications, collaborating cross-functionally and demonstrating exceptional writing prowess.
  • Serve as the primary liaison with global health authorities, ensuring transparent, proactive communication to achieve project milestones.
  • Oversee compliance with international regulatory guidelines for gene therapy products, including authoring and reviewing critical documentation.
  • Work closely with Nonclinical, Tech Ops, Quality, and Clinical teams to meet deadlines and secure timely approvals.

Qualifications:

  • Bachelor's degree in a relevant life sciences field with at least 8 years of experience in the biopharmaceutical industry, particularly with biologics and regulatory affairs.
  • Experience with gene or cell-based therapeutics, RNA-based therapeutics, or orphan drug development is highly preferred.
  • Proven track record with BLA or MAA submissions and extensive knowledge of global regulatory health authorities and submission types.
  • Exceptional communication skills, strategic leadership, and a commitment to high-quality, detail-oriented work.