Director of Regulatory Strategy

4 weeks ago

Cambridge, Massachusetts, United States Intellia Therapeutics, Inc. Full time
About the Role

We are seeking a highly skilled and experienced Director of Regulatory Strategy to join our team at Intellia Therapeutics, Inc. As a key member of our Regulatory Affairs group, you will 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, requiring cross-functional interactions and excellent writing skills.
  • Assume direct point of contact with health authorities, leading transparent and proactive interactions for project responsibilities.
  • Drive adherence to global regulatory guidelines relevant for the development of gene therapy products, authoring, reviewing, and approving internal documentation as necessary.
  • Partner closely with Nonclinical, Tech Ops, Quality, and Clinical groups to ensure achievement of submission deadlines and obtain timely approvals.
About You

We are looking for a detail-oriented candidate with a minimum of 8 years of relevant biopharmaceutical industry experience, ideally with biologics experience in Regulatory Affairs. A proven track record, including BLA or MAA experience, is essential. Expertise with drug development across all phases of clinical development, as well as deep experience with global regulatory health authorities (e.g. FDA, EMA) and different submission types, is required. Excellent written and verbal communication skills, including regulatory writing, are essential. Strong leadership skills, including strategic thinking, innovation, and mentorship, are also necessary.

Meet Your Future Team

The Regulatory Affairs group is a rapidly growing team within Intellia, including professionals with diverse regulatory expertise in both large pharma and small biotech settings. You will report to the Sr. Vice President, Regulatory Affairs, and will be part of a hardworking and collaborative environment. We look forward to fostering your skills, learning from your experiences, and building a larger team that will make a difference in patients' lives.

We are an equal opportunity employer and are committed to diversity and inclusion in the workplace. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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