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

– 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.

– 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.

– 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

– Classification and archiving of all MA files and regulatory information in databases.
– Rigorous maintenance of monitoring tables.

– Follow the evolution of French and international regulations in the field of activity of the company.

– 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

– 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