CMC Regulatory Writing Expert
3 days ago
This Senior CMC Regulatory Document Specialist role is responsible for preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.
Responsibilities- Prepare, review, and finalize regulatory submission documents for late-stage clinical applications (Phase 3) and marketing applications.
- Collaborate with CMC teams (formulation, process development, analytical, and manufacturing) to gather necessary information.
- Develop and maintain CMC regulatory dossier templates, ensuring compliance with evolving guidelines.
- Degree in Pharmacy, Chemistry, Biology, or a related field.
- At least 5 years of technical writing experience in CMC regulatory submissions.
- In-depth knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.
- Exceptional technical writing skills with the ability to clearly communicate complex scientific information.
- Competitive salary range: €65,000 - €85,000 per annum.
- Fully remote role with occasional travel to the R&D Centre in Paris, France.
- Opportunity to work on exciting projects and contribute to the development of groundbreaking therapies.
-
CMC Regulatory Affairs Expert
2 weeks ago
London, Greater London, United Kingdom Parexel Full timeJob DescriptionParexel Consulting seeks a seasoned CMC Regulatory Affairs Professional as a Regulatory Affairs Consultant. This role offers the opportunity to utilize expertise in CMC, exceptional communication skills, and strong writing experience, contributing to clients' success in the pharmaceutical industry.Key Responsibilities:Assisting in technical...
-
Senior Regulatory CMC Expert
1 month ago
London, Greater London, United Kingdom Cpl Healthcare Full timeCPL Life Sciences is collaborating with a global pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.As a Senior Regulatory CMC Expert, you will be responsible for the development of CMC Strategy for a range of projects in the development phase, including the preparation of CMC submissions for...
-
Regulatory CMC Manager
4 weeks ago
London, Greater London, United Kingdom Vertex Full timeAbout the JobThe Regulatory Chemistry Manufacturing Controls (CMC) Manager will play a key role in Vertex's execution of multi-product global regulatory CMC strategies for investigational and marketed products.This role contributes to the preparation and submission of regulatory CMC documentation and interactions with Health Authorities for CMC topics....
-
Regulatory CMC Professional
1 day ago
London, Greater London, United Kingdom Vertex Full timeAbout the RoleVertex is seeking a highly skilled Regulatory CMC Professional to lead our global regulatory chemistry strategy. This exciting opportunity will involve influencing the execution of multi-product regulatory strategies, contributing to regulatory submission preparation, and providing regulatory guidance to cross-functional teams.Key...
-
Regulatory CMC Team Lead
4 weeks ago
London, Greater London, United Kingdom Vertex Full timeVertex Job Opening: Regulatory CMC ManagerJob Summary:The Regulatory Chemistry Manufacturing Controls (CMC) Manager will significantly contribute to the execution of global regulatory CMC strategies for investigational and marketed products at Vertex. This role will prepare and submit regulatory CMC documentation, interact with Health Authorities for CMC...
-
Senior CMC Regulatory Document Specialist
3 days ago
London, Greater London, United Kingdom RBW Consulting Full timeJob TitleSenior CMC Regulatory Document SpecialistAbout the RoleThis pivotal position is instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.Key ResponsibilitiesPrepare, review, and finalize regulatory submission documents for...
-
Regulatory Content Developer
3 days ago
London, Greater London, United Kingdom RBW Consulting Full timeAbout UsRBW Consulting is a dynamic and innovative consulting firm that specializes in regulatory affairs for the pharmaceutical industry.Job OverviewWe are seeking a Senior CMC Regulatory Document Specialist to join our team and contribute to the development of groundbreaking therapies by ensuring the highest quality in regulatory...
-
CMC Regulatory Affairs Specialist
3 weeks ago
London, Greater London, United Kingdom Parexel Full timeRegulatory Affairs ConsultantParexel Consulting is seeking a seasoned CMC Regulatory Affairs Professional to collaborate with our team. As a Regulatory Affairs Consultant, you will utilize your expertise in CMC, excellent communication skills, and strong writing experience to contribute to our clients' success in the pharmaceutical industry.Key...
-
CMC Regulatory Leader
1 week ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout Us: GlaxoSmithKline (GSK) is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together.Job Summary: We are seeking an experienced Director of Policy and Regulatory Affairs to lead key strategic CMC regulatory activities for investigational and early commercial biological products.Key...
-
Senior Regulatory Affairs Director
3 weeks ago
London, Greater London, United Kingdom Lifelancer Full timeOtsuka Pharmaceutical Europe seeks a highly skilled Director CMC Regulatory Affairs to provide expertise on CMC regulatory matters for investigational and marketed products.The successful candidate will establish CMC regulatory strategies, ensuring Otsuka's products comply with global regulatory requirements. They will anticipate, develop, and recommend...
-
Regulatory Affairs Expert
7 days ago
London, Greater London, United Kingdom Parexel Full timeParexel Consulting is seeking a highly skilled Regulatory Affairs Consultant to join our team.">About the Job:">We are looking for an experienced professional with expertise in Clinical Trial Management and strong communication skills to contribute to the success of our clients in the pharmaceutical industry. This position offers exposure to novel...
-
London, Greater London, United Kingdom Parexel Full timeJob DescriptionParexel Consulting is a leading provider of CMC Regulatory Affairs Services. We are seeking a highly skilled and experienced professional to join our team as a Regulatory Affairs Specialist.In this role, you will have the opportunity to leverage your expertise in CMC, exceptional communication skills, and strong writing experience to...
-
CMC Regulatory Strategy Manager
23 hours ago
London, Greater London, United Kingdom Vertex Full timeJob DescriptionAs a CMC Regulatory Strategy Manager at Vertex, you will be responsible for developing and executing global regulatory CMC strategies for investigational and commercial products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory requirements.ResponsibilitiesReview Regulatory Submissions:...
-
Regulatory CMC Project Lead
4 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeJob Description:At RBW Consulting, we are seeking a highly skilled Regulatory CMC Project Manager to join our team. The successful candidate will be responsible for overseeing regulatory activities for a small molecule oncology product globally.This is a contract position until the end of March 2025, with a strong likelihood of extension for a further 6...
-
Regulatory CMC Project Leader
3 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeWe are seeking a skilled Regulatory CMC Project Manager to join our team at RBW Consulting.The successful candidate will be responsible for overseeing regulatory activities for a small molecule oncology product globally.This role involves working independently and with an outsourcing team on tasks such as change controls, out of specification assessments,...
-
Regulatory Manager
2 months ago
Uxbridge, London , Uxbridge, London, London, United Kingdom Parexel Full timeAre you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.As the CMC Regulatory Manager, you will play a vital role...
-
Regulatory Affairs Director, CMC Lead
1 week ago
London, Greater London, United Kingdom GSK Full timeOpportunity OverviewWe are seeking a highly skilled Regulatory Affairs Director to lead our Chemistry, Manufacturing and Controls (CMC) team. This role will provide strategic direction and guidance on global project and key business initiatives.The successful candidate will have significant experience in leading CMC regulatory activities for investigational...
-
London, Greater London, United Kingdom GlaxoSmithKline Full timeOverview of the RoleThis exciting opportunity is for a highly skilled and experienced Director of Regulatory Affairs, CMC to join our team at GlaxoSmithKline. As a key strategic partner, you will play a crucial role in representing Global Regulatory activities and driving strategic direction on global project and key business initiatives.Job DescriptionWe...
-
CMC Regulatory Affairs Specialist
7 days ago
London, Greater London, United Kingdom Parexel Full timeParexel Consulting is seeking a skilled Regulatory Affairs Consultant to join our team.">About the Role:">We are looking for an experienced professional with expertise in Clinical Trial Management and strong communication skills to contribute to the success of our clients in the pharmaceutical industry. This position offers exposure to novel technologies and...
-
Leading Financial Regulatory Lawyer
2 weeks ago
London, Greater London, United Kingdom CMC Markets Full timeCMC Markets is a leading online financial trading business that has been operating since 1989. With offices and branches in 13 countries, we offer a unique opportunity for a talented lawyer to join our global team.As a Legal Counsel at CMC Markets, you will be part of a full-service legal team that provides advice on capital markets, trading-related, and...