Regulatory Affairs Director
3 days ago
We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Annexon Biosciences. As a key member of our regulatory team, you will be responsible for providing global regulatory leadership and direction to support the development, registration, and life-cycle management of our innovative programs.
Key Responsibilities- Develop and implement regulatory strategies and plans to meet company objectives
- Collaborate with cross-functional teams to develop, coordinate, and implement regulatory submissions for global CTAs
- Provide strategic regulatory direction on programs to support the global regulatory plan, development plans, and clinical study designs
- Liaise with FDA, EMA, and other regulatory agencies as needed
- Oversee the preparation and submission of assigned sections of filings to regulatory authorities
- Lead and manage FDA/EMA meetings, including leading briefing documents and meeting minutes
- Maintain knowledge of and monitor changes in current global rules, regulations, and guidance governing drugs and biologics
- PhD/PharmD with 12+ years' experience in Regulatory Affairs or BS/MS/MSN with 14+ years' experience
- Experience in a successful leadership role in managing late-stage clinical candidate drugs
- Experience in working directly with the FDA and EMA
- Superior scientific writing skills for developing regulatory documents
- Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement, and patient care
- A stimulating and rewarding workplace with flexible work schedules, remote opportunities, and the ability to achieve a work-life balance
- A competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package
- A diverse and inclusive work environment that values diversity, equity, inclusion, and belonging
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Regulatory Affairs Director
3 days 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
1 day 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
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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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Senior Director Regulatory Affairs
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Regulatory Affairs Director
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South San Francisco, California, United States Alumis Full timeJob Title: Director, Regulatory StrategyAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. Our mission is to fundamentally change the outcomes for these patients.We are seeking an exceptional individual to provide leadership and support to global regulatory activities, driving Alumis'...
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Regulatory Affairs Director
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Regulatory Affairs Director
3 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
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San Francisco, California, United States Daiichi Sankyo, Inc. Full timeUnlock Your Potential in Regulatory AffairsDaiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to delivering innovative therapies to improve patient outcomes. We are seeking a highly skilled Regulatory Affairs Director to join our team and contribute to the success of our regulatory strategy.About the RoleThis is an exciting opportunity to...
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Regulatory Affairs Director
3 weeks ago
South San Francisco, California, United States Alumis Full timeJob Title: Regulatory Affairs DirectorAlumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. We are seeking an exceptional individual to provide leadership and support to global regulatory activities, driving our strategic vision for obtaining worldwide approvals to market our products.Key...
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Global Regulatory Affairs Director
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South San Francisco, California, United States Spectraforce Technologies Full timeJob Title: Global Regulatory Affairs Associate Director/DirectorLocation: South San Francisco, CA locationDuration: 06+ monthsDescription:Position Overview:We are seeking a highly skilled Regulatory Affairs Associate Director/Director to join our growing regulatory team. As the Global Regulatory Lead, you will develop and implement global regulatory...
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Global Regulatory Affairs Director
2 days ago
South San Francisco, California, United States Spectraforce Technologies Full timeJob Title: Global Regulatory Affairs Associate Director/DirectorLocation: South San Francisco, CADuration: 06+ monthsDescription:We are seeking a highly experienced Regulatory Affairs Associate Director/Director to join our growing regulatory team. As the Global Regulatory Lead, you will develop and implement global regulatory strategies to support the...
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Senior Director, Regulatory Affairs Lead
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South San Francisco, California, United States Structure Therapeutics Full timeJob Title: Senior Director, Regulatory AffairsStructure Therapeutics is seeking a highly experienced Senior Director, Regulatory Affairs to lead the development and execution of regulatory strategies and operations for our biotechnology products. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory...
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Senior Director of Regulatory Affairs
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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
3 days 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
3 days ago
South San Francisco, California, United States Abdera Therapeutics Full timeAbout Abdera TherapeuticsAbdera Therapeutics is a pioneering precision oncology company dedicated to developing innovative targeted radiation therapies. Our cutting-edge modular technology platform enables the rapid development of safe and efficacious treatments for cancer patients with limited options.Job SummaryWe are seeking a highly experienced...
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Regulatory Affairs Director
3 days ago
South San Francisco, California, United States Abdera Therapeutics Full timeAbout Abdera TherapeuticsAbdera Therapeutics is a pioneering precision oncology company dedicated to developing innovative targeted radiation therapies. Our cutting-edge technology platform enables the rapid development of safe and efficacious treatments for cancer patients with limited options.Job SummaryWe are seeking a highly experienced Regulatory...
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South San Francisco, California, United States BioSpace, Inc. Full timeJob SummaryAnnexon Biosciences is seeking an experienced Executive Director/Senior Director, Regulatory Affairs to provide global regulatory leadership and direction to support the development, registration, and life-cycle management of innovative programs within the Annexon portfolio.Key ResponsibilitiesDevelop and implement regulatory strategies and plans...
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Director, Regulatory Affairs
3 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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Regulatory Affairs Director
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Regulatory Affairs Director
3 days 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...