Regulatory Affairs Professional
2 days ago
We are seeking a highly experienced Regulatory Affairs professional to join our Clinical Trial Submissions (CTS) group. As a key member of our team, you will play a pivotal role in driving forward regulatory processes, ensuring compliance, and contributing to innovative clinical trials.
This is an ideal opportunity for someone with 4+ years of experience in Regulatory Affairs and a strong background in Clinical Trial Submissions. You will have the chance to work under a generous leader who is known for her authentic communication style and her genuine commitment to the growth and development of her team members.
You will be responsible for identifying and coordinating international, national, and local regulatory requirements for clinical trial submissions across various countries. Additionally, you will draft, review, and ensure the quality of all documents related to Clinical Trial Application (CTA) dossiers in accordance with local and regional regulations.
Your other responsibilities will include providing regulatory review of core study documents, performing quality control (QC) on CTA packages, maintaining and updating study status tracking tools, drafting and QC responses to client inquiries, creating and maintaining internal knowledge management tools, collaborating with subject matter experts, and liaising with regulatory authorities and service providers.
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Senior Regulatory Affairs Professional
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeRegulatory Affairs RoleWe are seeking a highly skilled Regulatory Affairs professional to support our Clinical Trial Submissions (CTS) group.This role is ideal for someone with experience in regulatory affairs and a strong background in Clinical Trial Submissions.Key ResponsibilitiesIdentify and coordinate international, national, and local regulatory...
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Regulatory Affairs Specialist
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...
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Regulatory Affairs Specialist
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Ltd Full timeRegulatory Affairs and Quality Assurance AssistantWe are seeking a highly skilled Regulatory Affairs and Quality Assurance Assistant to join our team at Newton Colmore Consulting Ltd. As a key member of our Medical Devices team, you will play a crucial role in ensuring the quality and regulatory compliance of our clients' products.Key...
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Regulatory Affairs Director
4 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...
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Regulatory Affairs Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob Overview At MoonLake Immunotherapeutics, we are seeking an experienced Associate Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s). Responsibilities * Collaborate with...
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Regulatory Affairs Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full timeAbout the RoleWe are seeking an experienced Regulatory Affairs professional to join our global team at Gilead Sciences International, Ltd.Key ResponsibilitiesDevelop and implement regulatory strategies for assigned products or projects.Collaborate with cross-functional teams to shape dossier content for global rollout and life cycle management.Oversee the...
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Regulatory Affairs Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeAbout the RoleMoonLake Immunotherapeutics is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Affairs. This is an exciting opportunity to contribute to the development and delivery of innovative global regulatory strategies for sonelokimab lead indication(s).Key ResponsibilitiesDevelop and implement...
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Regulatory Affairs Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeAbout the RoleMoonLake Immunotherapeutics is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Affairs. This is an exciting opportunity to contribute to the development and delivery of innovative global regulatory strategies for sonelokimab lead indication(s).Key ResponsibilitiesDevelop and implement...
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Regulatory Affairs Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob Title: Associate Director of Regulatory AffairsJob Summary:MoonLake Immunotherapeutics is seeking an experienced Associate Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for developing and implementing innovative global regulatory strategies for sonelokimab lead...
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Regulatory Affairs Director
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeJob Title: Associate Director, Regulatory AffairsJob Type: Permanent, full-timeLocations: Cambridge, UK – Hybrid/RemoteRemuneration: £85,000 - £110,000 + benefitsCpl Life Sciences is seeking a highly skilled Regulatory Affairs professional to lead strategy for development programs globally. As an Associate Director, Regulatory Affairs, you will support...
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Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Reed Engineering Full timeJob Title: Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Regulatory Affairs Specialist to lead our quality and regulatory projects and functions.Key Responsibilities:* Implement, maintain, and improve a comprehensive Quality Management System in accordance with relevant quality standards* Stay updated on global regulatory...
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Regulatory Affairs Director
2 weeks 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...
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Regulatory Affairs Specialist
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeRegulatory Affairs SpecialistWe are expanding our Clinical Trial Submissions (CTS) group and are seeking an experienced Regulatory Affairs professional to join our team. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions. You'll have the opportunity to work under a generous,...
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Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeRole Overview:We are seeking an experienced Regulatory Affairs professional to join our Clinical Trial Submissions (CTS) group. As a key member of our team, you will play a pivotal role in driving forward regulatory processes, ensuring compliance, and contributing to innovative clinical trials.Key Responsibilities:Identify and coordinate international,...
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Regulatory Affairs Program Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeRegulatory Affairs Program DirectorAt ProductLife Group, we are seeking a highly skilled Regulatory Affairs Program Director to join our team in the UK. As a key member of our Regulatory Affairs team, you will be responsible for piloting and managing Regulatory Affairs outsourcing projects/programs for major clients.About the RoleYou will act as a direct...
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Regulatory Affairs Program Director
1 month ago
Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full timeRegulatory Affairs Program DirectorAt ProductLife Group, we are seeking a highly skilled Regulatory Affairs Program Director to join our team in the UK. As a key member of our Regulatory Affairs team, you will be responsible for piloting and managing Regulatory Affairs outsourcing projects/programs for major clients.About the RoleYou will act as a direct...
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Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom https:jobs-redefined.cositemap Full timeSenior Regulatory Scientist (Clinical Trial Submissions)We are expanding our Clinical Trial Submissions (CTS) group and are seeking an experienced Regulatory Affairs professional to support our team. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.As part of a supportive...
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Regulatory Affairs Specialist
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom VCLS Full timeRole Overview:We are seeking a highly skilled Regulatory Affairs professional to join our Clinical Trial Submissions (CTS) group at VCLS. This role is ideal for someone with 4+ years of experience in regulatory affairs and a strong background in Clinical Trial Submissions.As part of a supportive and collaborative team, you'll play a key role in driving...
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Regulatory Affairs Director
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom CTI Clinical Trial and Consulting Services Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Director to join our team at CTI Clinical Trial and Consulting Services. As an Associate Director, Regulatory Affairs, you will play a critical role in developing and delivering innovative global regulatory strategies for our sonelokimab lead indication(s).Key Responsibilities:Develop and...
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Regulatory Affairs Manager
4 weeks ago
Cambridge, Cambridgeshire, United Kingdom Vectura Full timeRegulatory Affairs ManagerVectura Group is a global leader in developing innovative inhaled therapies and drug-device combination products (DDCPs). We are seeking a skilled and motivated Regulatory Affairs Manager to join our team and help drive the success of our medical device and DDCP regulatory activities.Key Responsibilities:Regulatory Leadership:...