(Senior) Regulatory Affairs Consultant - Submissions Manager

We are looking for Regulatory Affairs Professionals  on various levels for a client dedicated project within Parexel FSP Group. IN this role you will act as a Regulatory Affairs Registration Manager. You will be responsible for the maintenance of the worldwide vaccine licences by ensuring the planning/dispatch/submission/follow-up/approval of datapackages 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 etc.

This role can be home or office based in various European locations.

Job responsibilities: Coordinate and interact 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 timelinesEnsure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fullfilledPrepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspectsCoordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ansure deadlines are metMaintain close contacts with the Local Operating Compagnes’s (LOC’s) to ensure shared objectives are achievedEnsure the tracking of relevant correspondence with AuthoritiesCommunicate with external regulators on specific enquiriesBe responsible for Vaccine Registration activities of one or several projects - Identify key issues on registration activities that could prevent achieving objectives and proactively propose solutions

Skills and Expereinced required for the role:University degree (preferably biological/chemical)Ideally more than 3 years experience in the pharmaceutical industry; this should include at least 1-2 years RA experience.Knowledge of Regulatory legislation in at least one geographic areaBasic understanding of biologicals/vaccinesAnalytical capacityGood organizational skillsGood communication and presentation skillsFluent in English written and spoken