CMC Documentation Lead
3 weeks ago
We are seeking an experienced CMC Documentation Lead to join our Indivior team.
As a key member of our R&D CMC team, you will be responsible for leading the creation and maintenance of high-quality Module 3 documentation (CTD, IMPD, IND, NDA, ASMF, and DMF).
About the Role:The ideal candidate will have a deep understanding of ICH guidelines, EMA, and FDA regulations, as well as experience working in a fast-paced environment.
Responsibilities:- Lead the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers.
- Oversee the review and approval of regulatory submission documents.
- Prepare responses to questions raised by Healthcare Authorities.
- Collaborate with cross-functional teams to ensure project delivery and quality.
We offer a competitive salary of £62,000 - £82,000 per annum, flexible working arrangements, and a comprehensive benefits package.
Benefits:- A competitive salary.
- Flexible working arrangements.
- A comprehensive benefits package.
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Document Control Lead
3 weeks ago
Hull, Kingston upon Hull, United Kingdom Bilfinger Full timeJob OverviewBilfinger UK Limited is recruiting a Project Document Controller to manage project documentation and ensure smooth project delivery. The salary for this position is £45,000 - £60,000 per annum, depending on experience.ResponsibilitiesThe successful candidate will be responsible for:Managing project document registers, systems, and...
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Lead Regulatory Specialist
3 weeks ago
Hull, Kingston upon Hull, United Kingdom Indivior Full timeJob Summary:">">We are seeking a highly skilled Scientific Writer to join our Module 3 Dossier Development team in Hull, UK.">About the Role:">">As a Scientific Writer, you will be responsible for writing, reviewing and approving Module 3 documentation (CTD, IMPD, IND, NDA, ASMF and DMF) to support the development and maintenance of new and existing dossiers...
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Regulatory Affairs Scientist Lead
4 weeks ago
Hull, Kingston upon Hull, United Kingdom Indivior Full timeJob SummaryWe are looking for an experienced Regulatory Affairs Scientist Lead to join our R&D CMC team in Hull, UK. As a key member of the team, you will play a critical role in developing and maintaining new and existing dossiers for projects from Phase 1 inception through to the post-approval phase.About the RoleThe successful candidate will have...
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Regulatory Affairs Specialist
2 weeks ago
Hull, Kingston upon Hull, United Kingdom Indivior Full timeJob DescriptionIn this role, you will support the creation and maintenance of chemistry, manufacturing and controls information in Module 3 dossiers (CTD, IMPD, IND, MAA, NDA, ASMF and DMF), including Module 2.3 QOS, covering drug substance and drug product.You will write, review and approve regulatory submission documents and prepare responses to questions...
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Document Manager
4 weeks ago
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Dossier Developer
2 weeks ago
Hull, Kingston upon Hull, United Kingdom Indivior PLC Full timeWe are looking for a Dossier Developer to join our R&D CMC team in Hull, UK. As a key member of our team, you will be responsible for supporting the creation and maintenance of chemistry, manufacturing and controls information in Module 3 dossiers (CTD, IMPD, IND, MAA, NDA, ASMF and DMF), including Module 2.The successful candidate will have a Bachelor's...
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Senior Scientific Writer Lead
3 weeks ago
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Document Control Coordinator
4 weeks ago
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Project Administrator
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Engineering Documentation Coordinator
3 weeks ago
Hull, Kingston upon Hull, United Kingdom Bilfinger Full timeAbout the JobBilfinger UK Limited is seeking a skilled Project Document Controller to manage and control project documentation. This is a permanent position with a salary range of £42,000 - £58,000 per year, depending on experience.Key ResponsibilitiesThe successful candidate will be responsible for:Managing project document registers, systems, and...
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Document Management Specialist
4 weeks ago
Hull, Kingston upon Hull, United Kingdom Bilfinger Berger SE Full timeBilfinger UK is a leading engineering and maintenance provider, supporting customers across various industries including chemicals, nuclear, oil & gas, pharmaceuticals & biopharma, power & energy, utilities, renewables and food & beverage.We have extensive experience in offshore and onshore facilities, specialising in asset management services throughout all...
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Project Document Manager
4 weeks ago
Hull, Kingston upon Hull, United Kingdom Bilfinger Full timeCompany Overview:Bilfinger UK Limited is a leading engineering and maintenance provider, supporting customers across various markets. Our commitment to excellence is delivered by an experienced and highly competent workforce of over 4,500 employees.We enhance the efficiency of assets, ensuring a high level of availability and reducing maintenance costs. Our...
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Project Administrator and Document Specialist
2 weeks ago
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Project Document Management Specialist
3 weeks ago
Hull, Kingston upon Hull, United Kingdom Bilfinger Full timeAbout the RoleWe are seeking an experienced Project Document Controller to join our team at Bilfinger UK Limited. This is a permanent position that offers a competitive salary of £40,000 - £55,000 per annum, depending on experience.Job DescriptionThe successful candidate will be responsible for managing and controlling the flow of documents and information...
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Technical Documentation Coordinator
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Assistant Operations Lead
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Quality Assurance Project Lead
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Environmental Management Lead
1 month ago
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Industrial Safety Lead
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Engineering Innovation Lead
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