CMC Officer 833

ProductLife Group is looking for a CMC Officer to join our dynamic team in France.


About us

Group 10

  • Prepares CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
  • Reviews CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files)
  • Defines strategies for writing documents,
  • Defines positioning for variation files,
  • Evaluates the conformity of CMC documents according to the state of the art, current guidelines, local requirements and customer directives by performing gap analysis of regulatory documents.
  • Advises on pharmaceutical development: analysis of validation or stability reports.
  • Proposes to the client a strategy for validation, choice of specifications, stability plan.
  • Analyses and/or writes scientific reports based on raw data provided by the client
  • Regulatory compliance: comparison of analytical techniques and/or manufacturing processes between the MA file and factory procedures.
  • Carries out continuous regulatory monitoring/regulatory intelligence and communicates this to the teams
  • Contributes to the support and training of newcomers and colleagues (methodology, feedback,
  • Applies internal processes and templates as well as best practices of the profession
  • Reports any deviation or problem to his/her manager and proposes corrective or preventive actions
  • Contributes to the drafting of processes / procedures and templates to serve the performance of consulting activities

Group 13

We are looking for someone with the following qualities:

Knowledge of the module 3 writing, variation life cycle management

Knowledge of the European guidelines

Manage simple and complex projects.

Capabilities to assess change controls

Management of the time

Good communication

Good organization

Good IT knowledge : pack office, share point, …