CMC Regulatory Content Expert

Job DescriptionWe are seeking an experienced analytical or formulation specialist to join our team as a CMC Technical Content Expert. In this role, you will support the development of CMC technical content for our clients, working closely with cross-functional teams to ensure the highest quality submissions.Your expertise in CMC technical writing will enable...

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,...

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 SummaryProclinical Staffing seeks a skilled CMC Technical Content Creator to create and drive sections of the CMC dossier, ensuring compliance with regulatory requirements. The successful candidate will support technical functions in developing responses to health authority inquiries and ensure completeness, accuracy, and compliance of data for...

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...

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...

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.

We are seeking a talented CMC Technical Content Creator to join our team at RBW Consulting. As a highly skilled writer, you will be responsible for preparing new templates and taking hands-on responsibility for preparing, reviewing, and finalizing regulatory submissions. Your expertise in analytical science and technical writing will enable you to thrive in...

Regulatory Affairs Manager CMC biologicsYour new company This biopharmaceutical company specialises in rare diseases and is looking for a Regulatory Affairs Manager CMC contractor. This is a 12-month contract job with scope for monthsYour new role You will be responsible for EU and ROW markets, managing the authoring and compilation of all necessary CTD 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...

Job Summary:We are seeking an experienced Senior CMC Regulatory Technical Writer to join our team at RBW Consulting. 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.Responsibilities:Prepare,...

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 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...

Site Name: UK – London – New Oxford Street, Baar Onyx, Belgium-Rixensart, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidencePosted Date: Nov 19 2024Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting...

Site Name: UK – London – New Oxford Street, Baar Onyx, Belgium-Rixensart, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Nov 19 2024 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an...

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 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...

Regulatory CMC Project Manager - Contract Partnering with an international pharmaceutical company focused on both in house product development and CDMO services, we are now supporting the appointment of a new Regulatory CMC Project Manager to oversee regulatory activities for a small molecule oncology product globally. This position will be a contract until...

Job DescriptionProclinical is seeking a highly skilled CMC Author to join their team. This role requires a strong background in technical writing, regulatory compliance, and gene therapies. The successful candidate will be responsible for authoring and driving sections of the CMC dossier, ensuring timely and accurate quality submissions.About Proclinical...

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced Therapies sector. Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.We are looking for an experienced...