Regulatory Affairs Registration Manager

Our client is a pharmaceutical company and is looking for a regulatory affairs registration manager to take part to the management of their drug licenses. The RA registration manager will work at our client for at least 5 months.

The regulatory affairs registration manager:

. Is responsible for the maintenance of the worldwide vaccine licences by ensuring the planning/dispatch/submission/follow-up/approval of data-packages due to Regulatory Authorities: Variations, Commitments, Questions & Answers, PSURs/PBRERs, Risk Management Plans (RMPs), Renewals, Articles 46, Updated files, WHO Annual Reports, New Dossier requests
. Coordinates and interacts with the internal stakeholders (labelling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
. Ensures that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fulfilled
. Prepares cover letters, application forms, letters of intent, letters to request deadline extensions (Strong involvement in CTD Module 1)

The regulatory affairs registration manager is/has:

. University degree (preferably biological/chemical)
. Knowledge of Regulatory legislation in at least one geographic area
. Basic understanding of biologicals/vaccines
. Able to communicate in English (fluent - oral and written)
. At least 2 years of experience in RA

Keywords: RA, regulatory affairs, affaires réglementaires, RA, regulatory submission, RA