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CMC Dossier Writer

2 months ago

Hull, Kingston upon Hull, United Kingdom SRG Full time
About the Role

We 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 expertise will be leveraged to drive strategic decisions and mitigate risk.

Key Responsibilities
  • Support the development of Module 3 dossiers, including CTD, IMPD, IND, MAA, NDA, ASMF, and DMF.
  • Participate in strategy and planning meetings, risk assessments, and stakeholder interactions to drive informed decisions.
  • 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 UK-based recruitment company specializing in the science, engineering, clinical, pharmaceutical, food, and medical devices sectors. We pride ourselves on our sector knowledge and passion for delivering outstanding career opportunities for our candidates and expert recruitment services for our clients.