Regulatory Affairs – Senior CMC Dossier Manager

Job Title: Regulatory Affairs – Senior CMC Dossier Manager

Job Type: Contract position until December 2024, inside IR35

Rate: Up to £85ph PAYE or Umbrella

Location: 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;

·       Responsible, with limited guidance from the manager, for developing the technical eCTD sections to support Regulatory CMC dossier applications

·       Authors/drives, as 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 manager.

·       Experience in writing Regulatory CMC sections from scratch including CTA, IND, IMPD, BLA, NDA, and MAAs.

·       Supports the 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;

·       Life Science degree or equivalent

·       Minimum of 8 years’ experience related to Regulatory CMC

·       Must have experience with Microbial Vectors.

·       Previous experience authoring CMC BLA's from scratch.

If this opportunity is of interest to you please forward your up-to-date CV to [email protected]