Regulatory CMC Document Coordinator

Job Description: We are looking for a highly skilled CMC Regulatory Documentation Expert to join our team at RBW Consulting. In this role, you will be responsible for preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.Responsibilities:- Prepare,...

Job Title: Senior Regulatory CMC Document SpecialistAt RBW Consulting, we are seeking a highly skilled Senior Regulatory CMC Document Specialist to join our team. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical...

About the RoleThis is a challenging and rewarding opportunity to lead CMC regulatory activities for global biopharmaceutical products. You will work closely with cross-functional teams to ensure compliance with regulatory requirements and develop strategies to achieve business objectives.You will be responsible for leading key, strategic CMC regulatory...

About the RoleWe are seeking a Senior CMC Regulatory Technical Writer to join our dynamic CMC Regulatory Department. In this pivotal role, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.Main Tasks and...

Job SummaryWe are seeking a Director of Regulatory Affairs, CMC to serve as a key strategic partner representing Global Regulatory activities. This role will provide strategic direction and guidance on both global project and key strategic business initiatives.The successful candidate will lead key, strategic CMC regulatory activities for investigational and...

Job DescriptionResponsibilities:Regulatory Documentation and Submissions:Prepare high-quality CMC documentation for regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs) specific to cell therapy and ATMP products.Ensure compliance with global regulatory requirements for ATMPs, including gene therapies, tissue-engineered products, and somatic-cell...

Northreach's Vision:We aim to be a leader in developing innovative treatments for patients worldwide.To achieve this goal, we are looking for a talented Advanced Therapy Specialist to join our team.About the Job:The successful candidate will be responsible for preparing and reviewing high-quality CMC documentation for regulatory submissions.This includes...

Job Summary:The CMC Regulatory Affairs Manager will be responsible for maintaining high-quality standards and seeking continuous improvement in responding to evolving regulatory environments. This role will involve developing and implementing effective CMC regulatory strategies for late phase development and commercial lifecycle management of GSK...

**About Proclinical Staffing**We are a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. **Job Summary**We are seeking an experienced CMC Technical Writer to join our team. This is a remote working position that requires a high level of autonomy and accountability, with a...

Senior CMC Regulatory Technical Writer:We are seeking an experienced Senior CMC Regulatory Technical Writer to join our team at RBW Consulting. In this role, you will play a critical part in developing and maintaining high-quality CMC regulatory documents to support registration activities.Key Responsibilities:Develop and maintain regulatory documentation,...

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...

Job Title: Senior Pharmaceutical WriterWe are seeking a detail-oriented and skilled technical writer to join our team as a Senior Pharmaceutical Writer. This is a fully remote position with occasional travel to our R&D Centre in Paris, France.In this role, you will be responsible for preparing and submitting high-quality CMC regulatory documents to support...

Job SummaryWe are seeking an experienced CMC Regulatory Lead to join our team in the UK, responsible for ensuring compliance with regulatory requirements and providing strategic guidance on CMC regulatory activities. The successful candidate will play a critical role in supporting the development and commercialization of new medicines, working closely with...

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...

About the RoleIn this exciting opportunity, you will serve as a key strategic partner representing Global Regulatory activities. You will lead key, strategic CMC regulatory activities for investigational and early commercial biological products.

About the Role: RBW Consulting is seeking a Quality Assurance Technical Writer - CMC to join our team. As a Quality Assurance Technical Writer - CMC, you will be responsible for preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical therapeutic assets.Key...

Join GlaxoSmithKline as a Global Regulatory Manager and contribute to the success of our CMC organization. In this role, you will lead key, strategic CMC regulatory activities for investigational and early commercial biological products.About the RoleThe successful candidate will drive the CMC strategy, coordinate the timely preparation and author technical...

We are looking for a Regulatory Documentation Expert to join our team at Proclinical Staffing! As a leading life sciences recruiter, we understand the importance of finding the right person for the job.About the RoleThe successful candidate will be responsible for authoring and driving sections of the CMC dossier, ensuring compliance with regulatory...

Estimated Salary: £90,000 - £140,000 per yearBarrington James Limited is recruiting for a seasoned CMC Expert Consultant to join their growing consultancy in London. In this critical role, you will be responsible for providing technical regulatory advice to clients on CMC aspects of product development. You will work closely with cross-functional teams to...

At GlaxoSmithKline, we are seeking an experienced Regulatory Affairs Director to join our team. This role will provide strategic direction and guidance on global project and key strategic business initiatives within the Chemistry, Manufacturing and Controls (CMC) organization.About the RoleThe successful candidate will lead key, strategic CMC regulatory...