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Senior CMC Dossier Writer

2 months ago

Hull, Kingston upon Hull, United Kingdom SRG Full time
Job Title: Senior CMC Dossier Writer

We 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, 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.

If you have a strong background in analytical chemistry and experience working with Module 3 Dossiers, we encourage you to apply for this exciting opportunity. Please submit your CV and a cover letter outlining your relevant experience and qualifications.