CMC Specialist 824

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

About us

Responsibilities

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.
Regulatory compliance: comparison of analytical techniques and/or manufacturing processes between the MA dossier and factory procedures.
Carry out training sessions in CMC regulatory affairs.
Carry out a continuous regulatory watch/regulatory intelligence and communicate it to the teams
Contributes to the support and training of newcomers and colleagues (methodology, feedback,
tools)
Manages the client relationship, project control and contractual aspects as a project manager.

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, …