Regulatory Affairs Manager

Il y a 3 jours

OostVlaanderen, Oost-Vlaanderen, Belgique Patient Access Collaborative Temps plein 60 000 € - 100 000 €/an

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Management of local (BeNeLux) regulatory activities to obtain marketing authorizations for pharmaceutical products
Management and/or support of activities as Responsible for Information and Publicity (RIP)
Management of local (BeNeLux) pharmacovigilance activities including input to safety reports and management of ICSR as local QPPV
Contribution to reimbursement files by medical writing and/or budget impact analysis and RWE collection
Contribution to Medical Affairs projects such as development of patient journeys, slide decks for training, patient, HCP and marketing materials
Management of stakeholder interactions including advisory boards and scientific presentations
Involvement in medical information activities at local and global level. This entails replying to medical enquiries and relevant reporting of adverse events, technical complaints or special situations
Management of field market access research

Master/PhD degree in science (Biomedical sciences, Biotechnology, Pharmaceutical sciences, Drug Development, Medical Doctor, Biosciences), or equal through experience gained in Pharmaceutical Industry
Languages: Dutch/French/English (by preference native French or Dutch)
Previous experience in a pharmaceutical company or an agency providing consulting/clinical services to pharmaceutical industry is required
Having the technical regulatory knowledge of local/EMA regulatory requirements is required
Having previous exposure to RIP activities is a clear asset
First experience with local / EU GVP requirements is valuable
Strong interest to develop market access and medical affairs skills is required
Excellent stress and time management and ability to handle priorities and deadlines
Strong networker with ability to influence internal and external stakeholders
Team player - accountable and entrepreneurial