CMC Dossier Writer
1 week ago
We are seeking an experienced CMC Dossier Writer to join our team at SRG. As a global specialty pharmaceutical company, we are dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease.
This is a fantastic opportunity for an analytical chemist with experience working with Module 3 CMC Dossiers to join our dossier team on a 6-month initial contract. The successful candidate will support a range of critical projects and gain experience within CMC regulatory writing.
Key Responsibilities:
- Support the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers (CTD, IMPD, IND, MAA, NDA, ASMF, and DMF) covering drug substance and drug product.
- Actively participate in Module 3 strategy and planning meetings, risk assessments, and stakeholder interactions to leverage technical and regulatory expertise and insight.
- Write and review regulatory submission documents and prepare responses to questions raised by Healthcare Authorities.
- Support CMC changes in response to Regulatory Intelligence.
- Support CMC aspects of Change Control for existing Licenses.
Requirements:
- Degree or equivalent in a life science subject.
- Previous experience working with Module 3 Dossiers.
- Solid understanding of analytical chemistry.
SRG is the UK number 1 recruitment company specializing in the science, engineering, clinical, pharmaceutical, food/FMCG, renewable, biotech, chemicals, and medical devices sectors. We are committed to providing outstanding temporary, contract, and permanent career opportunities for our candidates and expert strategic recruitment services for our clients.
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CMC Dossier Writer
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Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterJob Summary:We are seeking an experienced CMC Dossier Writer to join our team at SRG. As a CMC Dossier Writer, you will be responsible for creating and maintaining chemistry, manufacturing, and controls information in Module 3 dossiers.Key Responsibilities:Support the creation and maintenance of chemistry, manufacturing, and...
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CMC Dossier Writer
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Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterJob Summary:We are seeking an experienced CMC Dossier Writer to join our team at SRG. As a CMC Dossier Writer, you will be responsible for creating and maintaining chemistry, manufacturing, and controls information in Module 3 dossiers.Key Responsibilities:Support the creation and maintenance of chemistry, manufacturing, and...
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Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterJob Summary:We are seeking an experienced CMC Dossier Writer to join our team at SRG. As a CMC Dossier Writer, you will be responsible for creating and maintaining chemistry, manufacturing, and controls information in Module 3 dossiers. This is a great opportunity to gain experience in CMC regulatory writing and could open the...
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Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterJob Summary:We are seeking an experienced CMC Dossier Writer to join our team at SRG. As a CMC Dossier Writer, you will be responsible for creating and maintaining chemistry, manufacturing, and controls information in Module 3 dossiers. This is a great opportunity to gain experience in CMC regulatory writing and potentially open...
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CMC Dossier Writer
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Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterJob Summary:We are seeking an experienced CMC Dossier Writer to join our team at SRG. As a CMC Dossier Writer, you will be responsible for creating and maintaining chemistry, manufacturing, and controls information in Module 3 dossiers. This is a great opportunity to gain experience in CMC regulatory writing and potentially open...
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CMC Dossier Writer
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Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterWe are seeking an experienced CMC Dossier Writer to join our team at SRG. As a key member of our dossier team, you will be responsible for creating and maintaining chemistry, manufacturing, and controls information in Module 3 dossiers.Key Responsibilities:Support the creation and maintenance of chemistry, manufacturing, and...
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Hull, Kingston upon Hull, United Kingdom SRG Full timeAbout the RoleWe are seeking an experienced CMC Dossier Writer to join our team at SRG, a leading recruitment company specializing in the science and pharmaceutical sectors.As a CMC Dossier Writer, you will play a critical role in supporting the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers. Your...
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Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterWe are seeking an experienced CMC Dossier Writer to join our team at SRG, a leading recruitment company specializing in the science, engineering, and pharmaceutical sectors.Job Summary:The successful candidate will have a strong background in analytical chemistry and experience working with Module 3 Dossiers. They will be...
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Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterWe are seeking an experienced CMC Dossier Writer to join our team at SRG, a leading recruitment company specializing in the science, engineering, and pharmaceutical sectors.Job Summary:The successful candidate will have a strong background in analytical chemistry and experience working with Module 3 Dossiers. They will be...
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CMC Dossier Writer
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Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterWe are seeking an experienced CMC Dossier Writer to join our team at SRG, a leading recruitment company specializing in the science, engineering, and pharmaceutical sectors.About the Role:Support the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers (CTD, IMPD, IND, MAA, NDA,...
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CMC Dossier Writer
1 week ago
Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: CMC Dossier WriterWe are seeking an experienced CMC Dossier Writer to join our team at SRG, a leading recruitment company specializing in the science, engineering, and pharmaceutical sectors.About the Role:Support the creation and maintenance of chemistry, manufacturing, and controls information in Module 3 dossiers (CTD, IMPD, IND, MAA, NDA,...
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Hull, Kingston upon Hull, United Kingdom SRG Full timeAbout the RoleWe are seeking an experienced CMC Dossier Writer to join our team at SRG, a leading recruitment company specializing in the science and pharmaceutical sectors.The successful candidate will have a strong background in analytical chemistry and experience working with Module 3 CMC Dossiers. They will be responsible for supporting the creation and...
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Hull, Kingston upon Hull, United Kingdom SRG Full timeAbout the RoleWe are seeking an experienced CMC Dossier Writer to join our team at SRG, a leading recruitment company specializing in the science and pharmaceutical sectors.The successful candidate will have a strong background in analytical chemistry and experience working with Module 3 CMC Dossiers. They will be responsible for supporting the creation and...
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Hull, Kingston upon Hull, United Kingdom SRG Full timeAbout the RoleWe are seeking an experienced CMC Dossier Writer to join our team at SRG, a leading recruitment company specializing in the science and pharmaceutical sectors.The successful candidate will have a strong background in analytical chemistry and experience working with Module 3 CMC Dossiers. They will be responsible for supporting the creation and...
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