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FSP - Regulatory Affairs Submissions Manager
Parexel International Corporation
United Kingdom, Remote
We are looking for a client dedicated role 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 timelines
Ensure that all regulatory aspects on the product safety/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fullfilled
Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1
Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects
Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ansure deadlines are met
Maintain close contacts with the Local Operating Compagnes’s (LOC’s) to ensure shared objectives are achieved
Ensure the tracking of relevant correspondence with Authorities
Communicate with external regulators on specific enquiries
Be 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 area
Basic understanding of biologicals/vaccines
Analytical capacity
Good organizational skills
Good communication and presentation skills
Fluent in English written and spoken
#LI-REMOTE
Job posted: 2022-09-24