Wavre, Walloon Region, Belgium
Manage regulatory activities in order to obtain Marketing Authorisations, obtaining the best possible label, and to maintain these authorisations. Determine from a strategic and scientific perspective the content of technical, pre-clinical and clinical sections of product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q&A, scientific consultations) to ensure that these documents meet high scientific standards and regulatory requirements. Act as the single point of Regulatory contact for product portfolio, plus other internal project related teams (e.g. access team, commercial team etc.) and possibly teams with the rest of GSK corporation. Participate to project discussions and provide strategic, scientific and RA input. Global Regulatory Plan (GRP) ownership and accountability. Ensure appropriate interactions with key authorities to obtain input on clinical, technical and/or non-clinical development strategy and, as appropriate, on the optimal regulatory pathway to follow to secure registration and/or approval of regulatory submissions for the given asset(s). Lead a regulatory team (6p) responsible for execution of the regulatory strategy for products under responsibility. Develop and motivate collaborators so to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
Consultant for several major pharmaceutical companies. Preparation, review, submission and follow-up of European regulatory applications (Mutual Recognition Procedures, variations, renewals, transfer of Marketing Authorisations, Orphan Drugs Designation) Technical documents writing (Investigational Medicinal Product Dossier, Investigation Brochure) RA strategy definition on Clinical Development Plans Coordination of global submissions of Clinical Trial Applications (EU and non EU countries) Obtained Certificates of Pharmaceutical Product from the AFFSAPS and MHRA for the export of medicinal products outside Europe.
Development of in vitro screening assays to identify modes of action of novel active ingredients against plants, insects or fungi (e.g. respiration or microtubulin inhibitors, inhibitors of acetylcholine esterase). Production of internal and external reports and SOP’s. Line-manager of two technicians. In charge of safety procedures in a lab of 15 people. Collaboration with external company (BDBiosciences, USA) for the development of new equipment. Communication of the data produced during multi-disciplinary meeting to decide the future of ongoing projects.
Development of in vitro screening assays to identify modes of action of novel active ingredients against plants, insects or fungi (e.g. respiration or microtubulin inhibitors, inhibitors of acetylcholine esterase). Production of internal and external reports and SOP’s. Line-manager of two technicians. In charge of safety procedures in a lab of 15 people. Collaboration with external company (BDBiosciences, USA) for the development of new equipment. Communication of the data produced during multi-disciplinary meeting to decide the future of ongoing projects.