Director of Regulatory Strategy
1 month ago
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.
- 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.
-
Director, Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeJob Title: Director, Regulatory StrategyAt Intellia Therapeutics, we are seeking a highly skilled and experienced Director, Regulatory Strategy to join our rapidly growing Regulatory Affairs team. As a key member of our team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global regulatory guidelines.Key...
-
Director, Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeJob Title: Director, Regulatory StrategyAt Intellia Therapeutics, we are seeking a highly skilled and experienced Director, Regulatory Strategy to join our rapidly growing Regulatory Affairs team. As a key member of our team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with global regulatory guidelines.Key...
-
Director, Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Full timeJoin Our Team as a Director, Regulatory StrategyAt Intellia, we're committed to pushing the boundaries of gene therapy and making a meaningful impact on patients' lives. As a Director, Regulatory Strategy, you'll play a critical role in shaping our regulatory strategy and ensuring compliance with global health authorities.Key Responsibilities:Develop and...
-
Director, Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Full timeJoin Our Team as a Director, Regulatory StrategyAt Intellia, we're committed to pushing the boundaries of gene therapy and making a meaningful impact on patients' lives. As a Director, Regulatory Strategy, you'll play a critical role in shaping our regulatory strategy and ensuring compliance with global health authorities.Key Responsibilities:Develop and...
-
Director of Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeDirector, Regulatory StrategyAt Intellia Therapeutics, we're committed to pushing the boundaries of gene therapy and developing innovative treatments for patients. 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...
-
Director of Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeDirector, Regulatory StrategyAt Intellia Therapeutics, we're committed to pushing the boundaries of gene therapy and developing innovative treatments for patients. 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...
-
Director of Regulatory Strategy
1 month ago
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeDirector, Regulatory StrategyAt Intellia Therapeutics, we're committed to pushing the boundaries of gene therapy and developing innovative treatments for patients. 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...
-
Director of Regulatory Strategy
1 month ago
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeDirector, Regulatory StrategyAt Intellia Therapeutics, we're committed to pushing the boundaries of gene therapy and developing innovative treatments for patients. 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...
-
Director of Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeDirector, Regulatory StrategyAt Intellia Therapeutics, we're committed to pushing the boundaries of gene therapy and developing innovative treatments for patients. 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...
-
Director of Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Therapeutics Full timeDirector, Regulatory StrategyAt Intellia Therapeutics, we're committed to pushing the boundaries of gene therapy and developing innovative treatments for patients. 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...
-
Director, Regulatory Strategy
1 month ago
Cambridge, Cambridgeshire, United Kingdom Intellia Full timeJob Title: Director, Regulatory StrategyAt 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...
-
Director, Regulatory Strategy
1 month ago
Cambridge, Cambridgeshire, United Kingdom Intellia Full timeJob Title: Director, Regulatory StrategyAt 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...
-
Director, Global Regulatory Strategy
4 days ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob OverviewMoonLake Immunotherapeutics is seeking a highly skilled Director, Global Regulatory Strategy to join our team. This is a critical role that will play a key part in shaping our regulatory strategy and ensuring the successful development and approval of our novel investigational Nanobody.The ideal candidate will have a strong background in...
-
Associate Director Regulatory Strategy
2 months ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob SummaryGilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs professional to join our global team as an Associate Director, Regulatory Affairs CMC. In this role, you will be responsible for acting as one of the EU Regulatory leads for our existing commercial and/or clinical programs.Key ResponsibilitiesDefine the regulatory...
-
Associate Director Regulatory Strategy
2 months ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob SummaryGilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs professional to join our global team as an Associate Director, Regulatory Affairs CMC. In this role, you will be responsible for acting as one of the EU Regulatory leads for our existing commercial and/or clinical programs.Key ResponsibilitiesDefine the regulatory...
-
Director, Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Full timeUnlock Your Potential as a Regulatory Affairs ExpertAt Intellia, we're on a mission to revolutionize the field of gene therapy. 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...
-
Director, Regulatory Strategy
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Intellia Full timeUnlock Your Potential as a Regulatory Affairs ExpertAt Intellia, we're on a mission to revolutionize the field of gene therapy. 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...
-
Regulatory Affairs Director
5 days ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000**Regulatory Affairs Director Role Overview**Cpl Life Sciences is seeking a highly experienced Regulatory Affairs Director to lead our global regulatory strategy and drive business growth.As a key member of our team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations and guidelines.**Key...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full time £85,000 - £110,000Associate Director, Regulatory AffairsCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to join our team. This is a permanent, full-time opportunity based in Cambridge, UK, with a hybrid/remote work arrangement.About the RoleWe are looking for a highly skilled and motivated individual to lead our regulatory affairs strategy...
-
Regulatory Affairs Director
2 months ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Gilead Sciences International, Ltd. as a Director, Global Regulatory Affairs, Precision Medicine.Key ResponsibilitiesDevelop and execute precision medicine regulatory strategies in alignment with the company's global regulatory strategy.Collaborate with...