CMC Regulatory Leader

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...

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 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...

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...

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...

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...

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 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 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.

Parexel 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...

Parexel 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...

**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...

Job SummaryWe are seeking a highly experienced CMC Strategy Lead to join our technical operations team at Orchard Therapeutics. The successful candidate will have substantial experience in the biotech/pharmaceutical industry, with a proven track record of managing cross-functional teams and delivering complex projects on time and within...

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 Meet and the RoleMeet is a pioneering pharmaceutical company committed to delivering innovative solutions for patients worldwide. We are seeking a highly skilled Chief CMC Officer to lead our research and development efforts, driving excellence in API and drug product development.Responsibilities:Develop and execute strategic CMC plans for APIs and...

Career Opportunity - Principal Consultant CMCBarrington James Limited invites applications from experienced regulatory professionals to fill the role of Principal Consultant CMC in our London office. As a senior member of our consultancy, you will lead CMC strategy development, manage projects, and mentor junior team members.Estimated Salary: £80,000 -...

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...

Risk Management Career Opportunity: Senior Risk Management Specialist - CMC MarketsAbout the PositionThis role presents a unique opportunity to take on a challenging leadership position within CMC Markets' Risk Team. As a Market Risk Analyst Leader, you will oversee the development and implementation of risk management strategies, working closely with...