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Regulatory Affairs Consultant - United Kingdom - Cpl Life Sciences
Description
Job Title:
Regulatory Affairs - Senior CMC Dossier Manager
Job Type:
Contract position until December 2024, inside IR35Rate: Up to £85ph PAYE or UmbrellaLocation: UK or Europe (Remote-based)CPL has partnered with a world-leading Biotech looking for an experienced Regulatory CMC leader to work on a developing rare disease portfolio.
This will be supporting two major projects and will be responsible for working as a Regulatory CMC Dossier Writer for complex developing biologics.
The preferred candidate has prior experience with Microbial Vectors and has experience writing and authoring CMC sections from conception to submission.
Job Responsibilities include;with limited guidance from the manager, for developing the technical eCTD sections to support Regulatory CMC dossier applicationsas appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations with limited guidance from the writing Regulatory CMC sections from scratch including CTA, IND, IMPD, BLA, NDA, and technical functions in the development of responses to health authority inquiries in support of major applications with limited guidance from the manager.
Candidate Requirements Include;Science degree or equivalentof 8 years' experience related to Regulatory CMChave experience with Microbial Vectors.experience authoring CMC BLA's from scratch.
If this opportunity is of interest to you please forward your up-to-date CV to