Description de l'annonce:

• 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