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.
- 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,
tools) - 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
