Director, Regulatory Strategy

1 month ago

Cambridge, Cambridgeshire, United Kingdom Intellia Full time
Job Title: Director, Regulatory Strategy

At Intellia, we're committed to advancing gene therapy and biopharmaceutical development. As a key member of our Regulatory Affairs 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.
  • Collaborate with cross-functional teams to prepare and submit high-quality dossiers and clinical trial applications in the US, EU, Japan, and ROW.
  • Establish and maintain relationships with global health authorities, leading transparent and proactive interactions to ensure project success.
  • Drive adherence to global regulatory guidelines, authoring and reviewing internal documentation to ensure conformance with regulations and existing approvals.
  • Partner with Nonclinical, Tech Ops, Quality, and Clinical groups to achieve submission deadlines and obtain timely 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, as well as deep experience with global regulatory health authorities.
  • Excellent written and verbal communication skills, including regulatory writing.
About Intellia:

Intellia is a rapidly growing biotechnology company dedicated to advancing gene therapy and biopharmaceutical development. Our team is passionate about making a difference in patients' lives, and we're committed to fostering a collaborative and inclusive work environment.

We are an equal opportunity employer and welcome applications from diverse candidates. If you're a detail-oriented professional with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.

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