CMC Dossier Writer
2 weeks ago
Job 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 controls information in Module 3 dossiers.
- Actively participate in Module 3 strategy and planning meetings, risk assessments, and stakeholder interactions.
- 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.
About SRG:
SRG is a leading recruitment company specializing in the science, engineering, clinical, pharmaceutical, food, 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.
-
CMC Dossier Writer
4 days ago
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...
-
CMC Dossier Writer
3 days ago
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...
-
CMC Dossier Writer
1 day ago
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...
-
CMC Dossier Writer
1 day ago
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...
-
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. 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...
-
CMC Dossier Writer
7 days 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. 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...
-
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. 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 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. 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 Dossier Writer
2 weeks ago
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...
-
CMC Dossier Writer
2 weeks ago
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...
-
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.Job Summary:The successful candidate will have a strong background in analytical chemistry and experience working with Module 3 Dossiers. They will be...
-
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.Job Summary:The successful candidate will have a strong background in analytical chemistry and experience working with Module 3 Dossiers. They will be...
-
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,...
-
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,...
-
CMC Dossier Writer
3 weeks ago
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...
-
CMC Dossier Writer
2 weeks ago
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...
-
CMC Dossier Writer
2 weeks ago
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...
-
CMC Dossier Writer
2 weeks ago
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...
-
CMC Dossier Writer
2 weeks ago
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...
-
Senior CMC Dossier Writer
4 days ago
Hull, Kingston upon Hull, United Kingdom SRG Full timeJob Title: Senior CMC Dossier WriterWe are seeking an experienced Senior 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,...
