Current jobs related to CMC Dossier Writer - Hull, Kingston upon Hull - SRG
-
Regulatory Scientist
4 weeks ago
Hull, Kingston upon Hull, United Kingdom Indivior Full timeJob Title: Lead Regulatory ScientistIndivior is a global specialty pharmaceutical company dedicated to developing medicines for substance use disorders and serious mental illnesses. We are seeking a highly skilled Lead Regulatory Scientist to join our Module 3 Dossier Development team.Job Summary:The successful candidate will be responsible for writing,...
-
Regulatory Scientist
4 weeks ago
Hull, Kingston upon Hull, United Kingdom Indivior Full timeJob Title: Lead Regulatory ScientistIndivior is a global specialty pharmaceutical company dedicated to developing medicines for substance use disorders and serious mental illnesses. We are seeking a highly skilled Lead Regulatory Scientist to join our Module 3 Dossier Development team.Job Summary:The successful candidate will be responsible for writing,...
-
Regulatory Science Team Lead
2 weeks ago
Hull, Kingston upon Hull, United Kingdom Indivior Full timeJob Summary:Indivior is seeking a skilled Regulatory Scientist to join our Module 3 Dossier Development team. As a key member of our team, you will be responsible for writing, reviewing, and approving Module 3 documentation, including CTD, IMPD, IND, NDA, ASMF, and DMF. This is an exciting opportunity to work on a wide range of projects from Phase 1...
-
Regulatory Scientist Lead
4 weeks ago
Hull, Kingston upon Hull, United Kingdom Indivior Full timeJob Summary:We are seeking a highly skilled Regulatory Scientist Lead to join our Module 3 Dossier Development team at Indivior. As a key member of our team, you will be responsible for writing, reviewing, and approving Module 3 documentation, including CTD, IMPD, IND, NDA, ASMF, and DMF.Key Responsibilities:Support the creation and maintenance of chemistry,...
-
Quality Officer
5 months ago
Kingston upon Hull, United Kingdom Summit Selection Full time**Quality Officer - Fixed 13 month contract** **DN39 - North Lincolnshire** **£30,000 - £32,000** **Monday to Friday - 8.30am -4.30pm** **25 days holiday plus bank holidays** Summit Selection are proud to be working with an industry leading agricultural business based in North Lincolnshire who are looking to add an experienced Quality Officer to their...
CMC Dossier Writer
2 months 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. This is a great opportunity to gain experience in CMC regulatory writing and potentially open the door to Regulatory Affairs positions.
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 passionate about providing outstanding temporary, contract, and permanent career opportunities for our candidates and expert strategic recruitment services for our clients.
