Our client are a major OTC healthcare manufacturer who are looking for a Senior R&D Compliance Associate to join their team based in Yorkshire. The successful candidate must have experience with CTD module 3 and have a pharmaceutical R&D background
The successful candidates will support the R&D compliance and maintenance team execute a review of CMC dossier sections/ technical documentation and processes for all global Health and Personal Care products.
Key accountabilities:
Work collaboratively with other members of the Compliance team and other personnel in Category R&D/ maintenance teams to provide Module 3 documentation for existing H&PC products for regulatory submission
Take existing documentation and reformat, modifying as required, in the eCTD format.
Gather existing documentation from R&D, Supply and Regulatory teams
Review current Module 3 documentation and obtain any information/documents required to ensure maintenance of compliance.
Look for opportunities to reduce technical complexity in Dossier information
Where licence variations are submitted without a full Module 3 provide appropriate analytical & formulation documentation to support the variations
Investigate and highlight opportunities for changing processes and procedures to reduce technical complexity
Provide R&D support in the preparation of responses to questions arising from the submission of any module 3 sections varied.
Apply the same principles to Medical Device and Cosmetic technical dossiers
Experience required:
It is essential that candidates have a strong R&D background (either analytical or formulation)
Experience of the preparation of elements of Module 3 of the eCTD, Medial Device and/ or Cosmetic Dossiers
In depth product knowledge of OTC pharmaceutical products, medical devices or personal care products
Ability to assess Module 3 elements against external standards (e.g. ICH guidelines and Notice to Applicants is highly desirable).
To apply for this position, candidates must be eligible to live and work in the UK
Matchtech is acting as an Employment Business in relation to this vacancy.