Regulatory Affairs

  • Development of regulatory strategies in collaboration with the various interlocutors
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    – Planning of regulatory affairs activities.
    – Development of various projects/strategies allowing optimization in the regulatory field.
  • Management of a drug portfolio
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    – Preparation of new recordings
    – Ensure the maintenance of the MAs obtained (renewals, variations) within the time limits
    – Budget planning of the portfolio of drugs made available
    – Preparation and filing of applications for marketing authorizations, variations (for medicines and clinical trials) or renewals to health authorities.
    – Monitoring of submission schedules, until final approval.
  • Communication with health authorities, regulatory subsidiaries, production sites, etc.
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    – Follow-up of MA requests, variations or renewals, answers to questions from administrations and collection of necessary complements.
    – Follow-up of sample requests from production sites.
  • Advertising control
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    – Generate outputs under SAS®: tables, listing, figures.
    – Interpret and present the statistical results of clinical studies
    – Write the statistical reports
    – Participate in the writing of publications, posters and abstracts
  • Updating regulatory databases
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    – Classification and archiving of all MA files and regulatory information in databases.
    – Rigorous maintenance of monitoring tables.
  • Regulatory monitoring: Develop and strengthen expertise in regulatory prerequisites
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    – Follow the evolution of French and international regulations in the field of activity of the company.
  • Publication of files: Assembly and reformatting of documents, formatting in e-CTD or NeeS format
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    – Carry out of documentary process : transform in e-CTD format and then constutute a file and publish the regulatory submission to the Health Authorities.
    – The publication must comply with the specifications in force, according to the various international requirements (e-CTD, NeeS, pdf format).
    – It also relies on an electronic management database for all regulatory documentation, as well as on publishing software.
    – Development, validation and distribution of texts relating to packaging items and product information
  • Quality Assurance: Preparation and Review of Module 3
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    – Writing and constitution of files: Q&A, module 3, module 2.3, PQVAR, CPID, PMF
    – Follow-up of actions related to each file in accordance with procedures in collaboration with laboratory teams and industrial sites
    – Coordination of CMC regulatory files: finalization of files, sending, archiving, reporting of activities