Director of Regulatory Affairs
2 months ago
Our client is a global leader in the development and commercialization of first-in-class robotic systems for the diagnosis and treatment of patients in need of advanced surgical interventions, including solid tumors. They have immediate need for a well-qualified Director of Regulatory Affairs to support an R&D team charged with developing effective small molecule (drug)-imaging agents.
- Lead New Drug Application (NDA) preparation activities, working in conjunction with CROs/internal development team
- Devise and execute regulatory plans tailored to the specific needs of the small molecule-focused imaging agent drug program
- Take ownership for all regulatory submissions through to NDA and post approval commitments, ensuring adherence to regulatory requirements and guidelines and interfacing with external consultants as necessary
- Support End of Phase (EOP) Type B meetings, collaborate cross-functionally to develop strategies on the meeting objectives and briefing materials
- Provide overall leadership of the regulatory function, interfacing with the Clinical, Quality Assurance and CMC teams
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Director, Regulatory Affairs
4 weeks ago
San Jose, California, United States Stryker Full timeJob Title: Director, Regulatory AffairsStryker Corporation is seeking a highly skilled and experienced Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing regulatory strategies to ensure compliance with international standards and government regulations.Key...
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Director, Regulatory Affairs
2 days ago
San Jose, California, United States Stryker Full timeRegulatory Affairs Director Job SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at Stryker. As a key strategist, you will be responsible for developing and implementing regulatory strategies for our Endoscopy business unit.Key Responsibilities:Develop and advise on product positioning, product entry and exit strategies,...
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Regulatory Affairs Director
2 weeks ago
South San Francisco, California, United States BioSpace, Inc. Full timeJob Title: Regulatory Affairs DirectorAlumis Inc. is seeking an exceptional Regulatory Affairs Director to provide leadership and support to global regulatory activities. The ideal candidate will have a strong background in regulatory affairs, with experience in developing and implementing regulatory strategies to facilitate the progress of assigned...
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Regulatory Affairs Director
4 weeks ago
San Diego, California, United States CorDx Full timeJob Title: Associate Director of Regulatory AffairsCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.Key Responsibilities:Prepare and submit regulatory...
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Regulatory Affairs Director
1 week ago
South San Francisco, California, United States BioSpace, Inc. Full timeJob Title: Regulatory Affairs DirectorAlumis Inc. is seeking an exceptional Regulatory Affairs Director to provide leadership and support to global regulatory activities. The ideal candidate will have a strong background in drug development, regulatory affairs, and immunology or rare disease/orphan drug development experience.Key Responsibilities:Develop and...
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Regulatory Affairs Director
2 weeks ago
South San Francisco, California, United States Synectics Full timeJob Title: Regulatory Affairs Associate Director/DirectorJoin Synectics, a leading pharmaceutical company, as a Regulatory Affairs Associate Director/Director and take on a challenging role in shaping the future of oncology drug development.Responsibilities:Develop and implement global regulatory strategies to support the development of multiple oncology...
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Regulatory Affairs Director
2 weeks ago
San Diego, California, United States Gossamer Bio Full timeJob SummaryWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Gossamer Bio. As a Director / Senior Director, CMC Regulatory Affairs, you will be responsible for developing and executing innovative CMC regulatory strategies in support of the global development and commercialization of a drug/device combination...
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Regulatory Affairs Director
2 days ago
South San Francisco, California, United States BioSpace, Inc. Full timeRegulatory Affairs DirectorWe are seeking a highly motivated individual to provide leadership and support to global regulatory activities to achieve our strategic vision in obtaining worldwide approvals to market our products.The individual will represent Regulatory Affairs and work closely with cross-functional teams and development partners while managing...
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Regulatory Affairs Director
1 week ago
San Diego, California, United States Codera Full timeJob Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...
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Regulatory Affairs Director
3 weeks ago
San Diego, California, United States Codera Full timeJob Title: Director, Regulatory AffairsCodera is a life-sciences focused investment company that creates, acquires and finances companies that develop and commercialize pharmaceutical products. We are seeking a highly skilled Director, Regulatory Affairs to support the development and execution of domestic and international regulatory strategy for Codera.Key...
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Regulatory Affairs Director
4 weeks ago
San Antonio, Texas, United States Extremity Care Full timeDirector of Regulatory AffairsAt Extremity Care, we are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team. This key role will be responsible for overseeing all regulatory matters, ensuring compliance with FDA and state requirements, AATB Standards, ISO Standards, and other applicable regulations.Key...
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Regulatory Affairs Director
2 days ago
San Diego, California, United States CorDx Full timeJob OverviewCorDx is a leading biotech organization dedicated to delivering innovative medical device solutions. We are seeking an experienced Associate Director of Regulatory Affairs to lead our regulatory submissions and ensure compliance with applicable regulations.This role will play a crucial part in the successful approval and launch of our medical...
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Associate Director Regulatory Affairs
4 weeks ago
San Diego, California, United States BioSpace, Inc. Full timeJob Title: Associate Director Regulatory AffairsAt BioSpace, Inc., we are seeking an experienced Associate Director Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for establishing regulatory strategies and plans, communicating with internal stakeholders, and ensuring compliance with...
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Executive Director
7 days ago
San Francisco, California, United States NextEra Energy , Inc. Full timeJob SummaryNextEra Energy, Inc. is seeking an Executive Director - Regulatory Affairs to lead our regulatory affairs efforts in the West Region. This role will be responsible for overseeing all regulatory affairs activities, including policy coordination, stakeholder engagement, and regulatory proceedings.Key Responsibilities:Develop and implement regulatory...
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Senior Director of Regulatory Affairs
1 week ago
San Francisco, California, United States KMR Search Group Full timeJob Title: Senior Director, Regulatory AffairsJob Description Job Summary:This role will support global CMC regulatory activities related to investigational/commercial large molecule biologic products. The Senior Director, Regulatory Affairs will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for...
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Senior Director Regulatory Affairs
2 weeks ago
South San Francisco, California, United States Structure Therapeutics Full timeJob Title: Senior Director, Regulatory AffairsStructure Therapeutics is seeking a seasoned Senior Director, Regulatory Affairs to lead the development and execution of regulatory strategies and operations for our products. As a key member of our leadership team, you will be responsible for guiding our products through development, approval, and post-approval...
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Senior Director Regulatory Affairs
2 weeks ago
San Francisco, California, United States KMR Search Group Full timeJob Title: Senior Director, Regulatory AffairsJob DescriptionJob Summary:This position will support global CMC regulatory activities related to investigational/commercial large molecule biologic products. The successful candidate will serve as a strategic business partner in providing regulatory CMC guidance to various development teams and for preparation...
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Regulatory Affairs Director
4 weeks ago
South San Francisco, California, United States Abdera Therapeutics Full timeJob Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...
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Regulatory Affairs Director
4 weeks ago
South San Francisco, California, United States Abdera Therapeutics Full timeJob Title: Director/Senior Director RegulatoryAbout Abdera TherapeuticsAbdera Therapeutics is a precision oncology company developing next-generation targeted radiation therapies. We are a rapidly growing company seeking key new team members who thrive at the cutting-edge of innovation.Job SummaryWe are looking for a highly experienced and skilled...
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Regulatory Affairs Director
6 days ago
South San Francisco, California, United States Abdera Therapeutics Full timeAbout the RoleAbdera Therapeutics is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies and contingencies for assigned programs, in order to support Abdera's development objectives.Key ResponsibilitiesLead and prepare FDA...