CMC Strategy Lead
6 days ago
Barrington James is seeking a seasoned regulatory expert to spearhead our CMC strategy initiatives. As a CMC Strategy Lead, you will be responsible for developing and executing innovative regulatory strategies that drive success in the pharmaceutical industry.
Key Responsibilities:- Design and implement comprehensive CMC regulatory plans
- Prepare and review critical regulatory documents, such as INDs, IMPDs, and MAAs
- Collaborate with regulatory agencies, ensuring effective communication and negotiation
- Manage project timelines, budgets, and deliverables, fostering a culture of excellence
- Provide guidance and mentorship to team members, promoting growth and development
- Pursue business opportunities, building strong relationships with clients
- Stay abreast of regulatory developments, ensuring compliance with evolving standards
Essential Qualifications:
- At least 8 years of experience in drug development and regulatory affairs
- Demonstrated expertise in FDA, EMA, and/or MHRA processes
- Proven track record in biologics, ATMPs, vaccines, or small molecules
- Advanced degree in life sciences (MSc or PhD preferred)
- Exceptional leadership, organizational, and time management skills
Salary: £100,000 - £120,000 per annum.
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CMC Strategy Lead
2 weeks ago
London, Greater London, United Kingdom Orchard Therapeutics Full timeAbout the RoleWe are seeking an experienced CMC Lead to join our Technical Operations team at Orchard Therapeutics. As a key member of our organization, you will play a critical role in driving the development and execution of our CMC strategy.You will be responsible for defining the CMC strategy for allocated programs, establishing project timelines,...
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CMC Strategy Lead
3 days ago
London, Greater London, United Kingdom Orchard Therapeutics Full timeJob 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...
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CMC Strategy Lead
2 weeks ago
London, Greater London, United Kingdom Barrington James Limited Full timeRegulatory Strategy Lead - CMCBarrington James Limited is seeking a highly skilled Regulatory Strategy Lead to join our team in London. As a key member of our consultancy, you will provide expert guidance on CMC aspects of product development, working closely with clients to achieve their goals.Estimated Salary: £80,000 - £110,000 per annumJob...
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CMC Strategy Lead
1 week ago
London, Greater London, United Kingdom Barrington James Full timeJob Title: CMC Strategy LeadBarrington James is recruiting for a Senior Consultant (CMC) to join our dynamic and growing global consultancy. This hybrid role is based in London, United Kingdom, with a flexible schedule and monthly office visits.Salary: £75,000 - £100,000 per annumJob Description:You will provide strategic and technical regulatory advice to...
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CMC Strategy Lead
2 weeks ago
London, Greater London, United Kingdom Barrington James Limited Full timeBarrington James Limited is recruiting for a Principal/Senior Consultant (CMC) to join their dynamic and growing global consultancy in London.This is a hybrid role with a flexible schedule and monthly office visits.Job OverviewThe successful candidate will provide strategic and technical regulatory advice to clients, focusing on CMC aspects of product...
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Director of CMC Strategy
1 month ago
London, Greater London, United Kingdom GlaxoSmithKline Full timeAbout 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...
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CMC Regulatory Strategy Manager
4 weeks ago
London, Greater London, United Kingdom Vertex Full timeJob DescriptionAs a CMC Regulatory Strategy Manager at Vertex, you will be responsible for developing and executing global regulatory CMC strategies for investigational and commercial products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory requirements.ResponsibilitiesReview Regulatory Submissions:...
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CMC Regulatory Lead
2 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...
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Full Stack Developer
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London, Greater London, United Kingdom CMC Markets Full timeSalary: £80,000 - £110,000 per annumJob Description:As a Senior Full Stack Developer at CMC Markets, you will be responsible for leading the development of new features for our core product and AI offering. You will work across both frontend and backend, collaborating closely with a product manager to deliver impactful solutions.Design and deploy APIs in...
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CMC Strategy Manager
3 days ago
London, Greater London, United Kingdom Orchard Therapeutics Full timeAbout Us:We are Orchard Therapeutics, a leading biotechnology company dedicated to developing innovative treatments for rare genetic disorders.We are committed to providing a dynamic and supportive work environment that fosters collaboration and innovation.In this role, you will have the opportunity to work with a talented team of professionals who share...
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Growth Strategy Director
2 weeks ago
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Regulatory CMC Professional
4 weeks ago
London, Greater London, United Kingdom Vertex Full timeAbout 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...
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CMC Regulatory Leader
1 month ago
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Pharma CMC Development Lead
2 weeks ago
London, Greater London, United Kingdom Planet Pharma Full timeWe are seeking a highly skilled Pharma CMC Development Lead to join our team at Planet Pharma. As a key member of our operations group, you will be responsible for managing CMC activities and providing strategic support to Global Operations and R&D groups.The estimated salary for this position is $150,000 - $220,000 per year, based on industry standards and...
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Global IT Project Lead
2 weeks ago
London, Greater London, United Kingdom CMC Markets Full timeAbout the RoleCMC Markets is an equal opportunities employer and we are currently seeking a Global IT Project Lead to join our team. As a Global IT Project Lead, you will be responsible for managing the flow of work coming into the team, escalating internally and to external vendors where necessary.You will work with a team of customer-focused professionals...
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Principal Consultant CMC
2 weeks ago
London, Greater London, United Kingdom Barrington James Limited Full timeCareer 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 -...
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CMC Regulatory Professional
2 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...
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Frontend and Backend Lead Developer
2 weeks ago
London, Greater London, United Kingdom CMC Markets Full timeEstimated Salary: £100,000 per annumAbout the Role:We are seeking a highly skilled Full Stack Developer to join our team at CMC Markets. As a key member of our development team, you will be responsible for leading the development of new features for our core product and AI offering.You will work closely with our product manager to deliver impactful...
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CMC Regulatory Expert
6 days 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...
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CMC Lead Consultant
2 weeks ago
London, Greater London, United Kingdom Barrington James Full timeWe are seeking a Senior Regulatory Strategist to join our team at Barrington James, a leading global consultancy.About the RoleThis is a hybrid role based in London, United Kingdom, with a flexible schedule and monthly office visits. The ideal candidate will have extensive experience in regulatory affairs, particularly in the areas of CMC, and will be able...