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Senior CMC Dossier Writer

2 months ago

Hull, Kingston upon Hull, United Kingdom SRG Full time

Job Title: CMC Dossier Development Specialist

Job Type: 6 Month Contract - Potential to Extend

Salary: Competitive and Negotiable

Location: Remote - Hybrid Working Possible

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

We are seeking an analytical chemist with experience working with Module 3 CMC Dossiers to join our dossier team on a 6 month initial contract to support critical projects. This is a great opportunity to gain experience within 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 (CTD, IMPD, IND, MAA, NDA, ASMF and DMF) covering drug substance and drug product.
  • Participate in Module 3 strategy and planning meetings, risk assessments and stakeholder interactions to leverage 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.

Requirements:

  • Degree or equivalent in a life science subject.
  • Previous experience working with Module 3 Dossiers.
  • Solid understanding of analytical chemistry.