Regulatory Strategy Director
4 days ago
Job Summary:
The Director of Regulatory Strategy will play a key role in shaping the regulatory strategy for Intellia Therapeutics' gene therapy products. This is a hands-on role that requires a deep understanding of regulatory requirements and a strong ability to communicate complex scientific issues to various stakeholders.
Key Responsibilities:
- Develop and implement regulatory strategies for assigned projects, ensuring compliance with global regulatory guidelines.
- Manage the preparation and submission of high-quality dossiers and clinical trial applications in the US, EU, Japan, and ROW.
- Lead interactions with global health authorities, ensuring transparent and proactive communication.
- Partner with cross-functional teams to ensure achievement of submission deadlines and obtain timely approvals.
- 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.
- Deep experience with global regulatory health authorities.
- Excellent written and verbal communication skills, including regulatory writing.
About Intellia Therapeutics:
Intellia Therapeutics is a rapidly growing biotechnology company focused on developing gene editing therapies for a range of diseases. Our team is passionate about making a difference in patients' lives, and we are committed to fostering a collaborative and inclusive work environment.
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