Regulatory Affairs Specialist
3 days ago
AbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to ensure compliance with regulatory requirements.
Key Responsibilities:- Develop and implement regulatory strategies to ensure compliance with global regulations.
- Collaborate with cross-functional teams to ensure regulatory requirements are met.
- Prepare and submit regulatory documents, including IND/CTA applications and marketing authorization applications.
- Provide regulatory support and guidance to teams and departments.
- Stay up-to-date with changing regulatory requirements and ensure compliance.
- Bachelor's degree in a relevant field, such as pharmacy, biology, or chemistry.
- At least 6 years of experience in regulatory affairs, R&D, or a related field.
- Strong knowledge of regulatory requirements and guidelines.
- Excellent communication and project management skills.
AbbVie offers a comprehensive benefits package, including medical, dental, and vision insurance, as well as a 401(k) plan. We are an equal opportunity employer and are committed to diversity and inclusion.
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Regulatory Affairs Specialist
1 week ago
San Francisco, California, United States Yoh Full timeRegulatory Affairs Specialist Job DescriptionYoh is seeking a highly skilled Regulatory Affairs Specialist to join our team in St. Louis, Missouri. This individual will be responsible for planning and authoring pharmaceutical documents, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.Key Responsibilities:Plan...
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Regulatory Affairs Specialist
3 days ago
South San Francisco, California, United States AbbVie Full timeJob Title: Regulatory Affairs ManagerAbbVie is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our regulatory team, you will be responsible for providing strategic guidance and support to our global development teams.Key Responsibilities:Develop and implement regulatory strategies for assigned products or...
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
3 weeks ago
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Regulatory Affairs Specialist
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San Mateo, California, United States Collabera Full timeJob Title: Regulatory Affairs SpecialistCollabera is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the pharmaceutical industry.Key Responsibilities:Perform data entry and maintenance of...
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Regulatory Affairs Specialist
1 week ago
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Regulatory Affairs Specialist
4 weeks ago
San Francisco, California, United States Balchem Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Compliance and Regulatory Affairs Department, you will play a critical role in ensuring our organization's compliance with state and federal regulations.Key ResponsibilitiesSubmit regulatory reports, including the annual Timely Access Report, to...
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Senior Regulatory Affairs Specialist
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Regulatory Affairs Specialist
2 weeks ago
San Mateo, California, United States RICEFW Technologies Full timeJob Title: CMC Regulatory Affairs Data Entry SpecialistRICEFW Technologies is seeking a highly skilled and detail-oriented CMC Regulatory Affairs Data Entry Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for performing data entry using Gilead RIM System to support key CMC RA stakeholders.Key...
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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
2 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 drug development, regulatory affairs, and immunology or rare disease/orphan drug development experience.Key Responsibilities:Develop and...
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Regulatory Affairs Specialist II
3 days ago
San Francisco, California, United States Volt Full timeJob Title: Regulatory Affairs Specialist II - Medical DeviceVolt is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Develop and implement regulatory strategies for...
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Senior Regulatory Affairs Specialist
3 weeks ago
South San Francisco, California, United States insitro Full timeAbout the RoleAt insitro, we're revolutionizing the way we approach drug discovery and development using machine learning and data at scale. We're seeking a highly skilled and experienced Regulatory Affairs professional to join our team as a Global Regulatory Lead. In this role, you'll be responsible for developing and implementing global regulatory...
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Regulatory Affairs Specialist
1 month ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs Specialist **About the Role** We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ACON Laboratories. As a key member of our regulatory affairs team, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements. **Key Responsibilities** *...
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Regulatory Affairs Specialist
4 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...
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Regulatory Affairs Specialist
3 days ago
San Diego, California, United States ACON Laboratories Full timeSenior Regulatory Affairs SpecialistAt ACON Laboratories, we are committed to developing innovative medical devices that enhance human life. We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team.The ideal candidate will have a strong background in medical devices regulations and terminologies, with a minimum of 6-7 years of...
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Regulatory Affairs Director
4 weeks ago
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 Specialist
2 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...
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Regulatory Affairs Director
3 days 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 Specialist
4 weeks ago
San Diego, California, United States Tandem Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Tandem Diabetes Care. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our medical devices.Key ResponsibilitiesPrepare and maintain domestic and international regulatory filings...