Director of Regulatory Strategy

1 month ago


Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full time
Director, Regulatory Strategy

At Intellia Therapeutics, we're committed to pushing the boundaries of gene therapy and developing innovative treatments for patients. As a key member of our team, you'll play a critical role in shaping our regulatory strategy and ensuring compliance with global health authorities.

Key Responsibilities:
  • Develop and implement regulatory strategies for assigned projects, ensuring alignment with company goals and objectives.
  • Manage the preparation and submission of high-quality dossiers and clinical trial applications in the US, EU, Japan, and ROW.
  • Collaborate with cross-functional teams to drive adherence to global regulatory guidelines and ensure timely approvals.
  • Partner with health authorities to lead transparent and proactive interactions, ensuring seamless project execution.
  • Author, review, and approve internal documentation to ensure conformance with regulations and existing regulatory approvals.
Requirements:
  • Master's or Ph.D. in biochemistry, chemistry, biology, or biochemical engineering, or related life science field.
  • Minimum 8 years of relevant biopharmaceutical industry experience, ideally with biologics experience in Regulatory Affairs.
  • Expertise with drug development across all phases of clinical development and deep experience with global regulatory health authorities.
  • Excellent written and verbal communication skills, including regulatory writing.

We're looking for a detail-oriented and strategic thinker who can drive our regulatory strategy forward. If you're passionate about gene therapy and regulatory compliance, we'd love to hear from you.



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