CMC Regulatory Strategy Manager

About 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....

About 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...

Vertex 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...

About 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...

About the Role: We are looking for an experienced professional to join our team as a Director of Policy and Regulatory Affairs. This role will be responsible for leading key strategic CMC regulatory activities for investigational and early commercial biological products.Key Responsibilities:Lead key, strategic CMC regulatory activities for investigational...

CPL 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...

Job 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...

Otsuka 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...

Opportunity 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...

We 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 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...

Job 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...

Job DescriptionThis 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.ResponsibilitiesPrepare, review, and finalize regulatory submission documents for late-stage clinical...

Job 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...

About 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...

About the Role:As a CMC Director, you will be responsible for providing strategic direction and guidance on both global project and key strategic business initiatives within Global Regulatory Affairs. You will lead key, strategic CMC regulatory activities for investigational and early commercial biological products, and drive the CMC strategy to support...

Job Title: CMC Markets CounselAn exciting opportunity has arisen for a highly skilled CMC Markets Counsel to join our team.Salary: £95,000 - £115,000 per annumAbout the Role:This is an onsite role requiring you to be in our London office 5 days a week.As a key member of our full-service legal team, you will assist the Head of Legal, Senior Legal Counsel,...

Are 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...

Overview 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...

Job 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...