CMC Regulatory Document Specialist
3 weeks ago
**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 focus on timely and accurate quality submissions.
**Responsibilities**
- Author and drive sections of the CMC dossier, ensuring compliance with regulatory requirements.
- Support technical functions in developing responses to health authority inquiries.
- Ensure completeness, accuracy, and compliance of data for regulatory submissions.
- Contribute to dossier strategy and product development plans.
- Lead and supervise dossier authoring activities for early and late-stage projects.
- Identify and implement business improvements within the functional organization.
- Interface with CMC/Tech team members, regulatory bodies, external service providers, and internal stakeholders.
**Key Skills and Requirements**
- A PhD alongside post-doc experience and relevant years of working experience OR University degree with proven years of relevant experience.
- Recent BLA experience for recombinant proteins is a necessity.
- Strong background in gene therapies, technical dossier writing, and development.
- Ability to work independently with limited guidance.
- Excellent communication and team-working skills.
- Experience in managing complex projects and leading programs.
- Ability to identify and implement innovative approaches to improve products and processes.
**Estimated Salary Range:** $120,000 - $180,000 per annum, depending on experience.
-
Senior Regulatory CMC Document Specialist
4 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeJob 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...
-
CMC Regulatory Documentation Expert
4 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeJob 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,...
-
CMC Regulatory Expert
3 weeks ago
London, Greater London, United Kingdom Northreach Full timeNorthreach'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...
-
CMC Regulatory Professional
4 weeks ago
London, Greater London, United Kingdom Northreach Full timeJob 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...
-
Senior Regulatory Writer
4 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeAbout 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 Documentation Specialist
3 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeJob 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...
-
CMC Regulatory Affairs Manager
2 weeks ago
London, Greater London, United Kingdom ENGINEERINGUK Full timeJob 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...
-
CMC Regulatory Strategist Leader
2 weeks ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout 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...
-
Director of Regulatory Affairs CMC
2 weeks ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob 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...
-
Regulatory Documentation Expert
4 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeSenior 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,...
-
CMC Regulatory Leader
2 months 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...
-
CMC Regulatory Lead
4 weeks ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeJob 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...
-
Advanced Therapies CMC Specialist
3 weeks ago
London, Greater London, United Kingdom Northreach Full timeKey Responsibilities:We are seeking a highly skilled and detail-oriented Regulatory CMC Specialist to join our team. This is an exciting opportunity to contribute to cutting-edge treatments in the Advanced Therapies sector.About the Role:Prepare and review high-quality CMC documentation for regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs) specific...
-
CMC Regulatory Expert
4 weeks ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout 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.
-
Regulatory Affairs Specialist
2 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeSenior CMC Regulatory Technical WriterWe are seeking a detail-oriented Senior CMC Regulatory Technical Writer to join our dynamic CMC Regulatory Department. As a key member of the team, you will be instrumental in preparing and submitting high-quality CMC regulatory documents to support registration activities for both small molecule and biopharmaceutical...
-
Regulatory Manager
3 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...
-
Quality Assurance Technical Writer
4 weeks ago
London, Greater London, United Kingdom RBW Consulting Full timeAbout 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...
-
Global Regulatory Specialist
4 weeks ago
London, Greater London, United Kingdom CV Library Full timeJob Title: Global Regulatory SpecialistAbout the Company:CV Library is a leading provider of career opportunities in the pharmaceutical industry. We are committed to delivering high-quality services to our clients and candidates.About the Role:We are seeking a highly skilled Global Regulatory Specialist to join our team. As a key member of our regulatory...
-
Advanced Therapies Regulatory Expert
3 weeks ago
London, Greater London, United Kingdom Northreach Full time**Job Description:**Northreach is seeking an experienced Regulatory CMC Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for driving regulatory compliance for transformative therapies.Responsibilities:Regulatory Document Preparation:Prepare and review high-quality CMC documentation for regulatory...
-
Regulatory Documentation Expert
3 weeks ago
London, Greater London, United Kingdom Proclinical Staffing Full timeWe 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...