Senior CMC Dossier Writer - SRG : Job Details

Have you worked with Module 3 Dossiers within a CMC environment and are looking for your first opportunity working outside the lab in an exciting and rapidly growing company?

Job Title: Dossier Development Scientific Writer

Type: 6 Month temp - Potential to extend

Salary: DOE and Negotiable

Location: Hull, England, Hybrid - Remote working is possible for the right candidate.

SRG is currently working exclusively with a global specialty pharmaceutical company that is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease.

As a result of expansion, we are looking for an analytical chemist who has experience working with Module 3 CMC Dossiers to join the dossier team on a 6 month initial contract to support with a range of critical projects. This is a GREAT opportunity to gain experience within CMC regulatory writing, and could open the door to Regulatory Affairs positions.

If you have worked on any of the following sections, please get in touch! Please outline in your CV how you fit the below requirements.

Module 3

32S Drug Substance

32S1 General Information

32S2 Manufacture

32S3 Characterization

32S41 Control of Drug Substance

32S5 Reference Standards or Materials

32S6 Container Closure System

32S7 Stability

32P Drug Product

32P1 Description and Composition of the Drug Product

32P2 Pharmaceutical Development

32P3 Manufacture

32P4 Control of Excipients

32P5 Control of Drug Product

32P6 Reference Standards or Materials

32P7 Container Closure System

32P8 Stability

Typical responsibilities/accountabilities:

• 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 your technical and regulatory expertise and insight, to drive the right decisions at the right time and mitigate risk.
• 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 Licences

Essential Requirements:

• Degree or equivalent in a life science subject.
• Previous experience working with Module 3 Dossiers as highlighted above
• A solid understanding on analytical chemistry

If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV to Selby at Selby. For more information regarding this position or any others, please call Selby on .

If you have a scientific background and this position is not relevant / suitable for you please feel free to get in touch or visit www.srg.co.uk to view our other vacancies.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.