Ar

Regulatory Affairs

– Planning of regulatory affairs activities.
– Development of various projects/strategies allowing optimization in the regulatory field.

– Preparation of new registrations
– Ensure the maintenance of marketing authorizations obtained (renewals, variations) within the time required
– Budgetary planning of the portfolio of medicines available
– Preparation and submission of marketing authorization application files and variations (pharmaceutical and clinical) or renewals with health authorities.
– Monitoring of submission schedules, until final approval.

– Monitoring of MA applications, variations or renewals, answers to questions from administrations and collection of necessary supplements.
– Monitoring sample requests from production sites.

– Suivi des demandes d’échantillons auprès des sites de productions.

– Generate outputs under SAS®: tables, listing, figures.
– Interpret and present the statistical results of clinical studies
– Write the statistical report
– Participate in the writing of publications, posters and abstracts

– Classification and archiving of all marketing authorization files and regulatory information within the databases.
– Rigorous maintenance of monitoring tables.

– Monitor the evolution of French and international regulations in the company’s field of activity.

– Achieve documentary processing: formatting in e-CTD format. Then prepare and publish the regulatory submission to the Health Authorities.
– The publication must comply with the applicable specifications, according to the various international requirements (e-CTD, NeeS, pdf format).
– It also relies on an electronic management database of all regulatory documentation, as well as publishing software.

– La publication doit être conforme aux spécifications en vigueur, selon les différents requis internationaux (e-CTD, NeeS, format pdf).
– Elle s’appuie également sur une base de données de gestion électronique de l’ensemble de la documentation réglementaire, ainsi que sur le logiciel de publishing.

  • – Writing and constitution of files: Q&A, module 3, module 2.3, PQVAR, CPID, PMF
    – Monitoring of actions linked to each file in accordance with procedures in collaboration with laboratory teams and industrial sites
    – Coordination of CMC regulatory files : finalization files, sending, archiving, reporting of activities

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