Associate Director Regulatory Strategy

5 days ago


Cambridge, Massachusetts, United States BioSpace, Inc. Full time
Job Title: Associate Director, Regulatory Strategy About the Role: We are seeking an experienced Associate Director to lead our regulatory strategy efforts. As a key member of our Regulatory Affairs team, you will be responsible for developing and implementing regulatory strategies to support the development and approval of our gene therapies. Key Responsibilities: * Develop and implement regulatory strategies to support clinical development and registration of gene therapies * Interpret regulations, policies, and guidelines to advise cross-functional teams on regulatory requirements * Lead the planning, preparation, and execution of regulatory submissions for assigned programs * Represent regulatory on the program team and present to company committees as needed * Serve as a liaison within internal departments at Intellia, with CROs, and with regulatory personnel at the various Health Authorities Requirements: * Minimum B.S. in biochemistry, chemistry, biology, or biochemical engineering, or related life science field, with a minimum of 6 years of relevant biopharmaceutical industry experience, ideally with biologics experience in Regulatory Affairs * Preferred experience would include gene or cell-based therapeutics, RNA-based therapeutics, and/or orphan drug development * A proven track record, ideally with BLA or MAA experience * Expertise with drug development across all phases of clinical development is required as well as deep experience with global regulatory health authorities (e.g. FDA, EMA) and different submission types * Excellent written and verbal communication skills, including regulatory writing, are essential About Intellia: Intellia is a rapidly growing biotechnology company dedicated to developing curative genome editing treatments for severe and life-threatening diseases. Our mission is to transform the lives of people living with these diseases by developing innovative solutions that address the root causes of these conditions. What We Offer: * A dynamic and collaborative work environment with a talented team of professionals * Opportunities for professional growth and development in a rapidly evolving industry * A competitive compensation and benefits package How to Apply: If you are a motivated and results-driven individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity. Please submit your resume and a cover letter outlining your qualifications and experience.

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