Beschrijving van de functieContracting - Brabant WallonEvaluate the specificities and regulatory requirements of the markets associated with the submission of internal portfolio onto these markets. Define the strategy for the registration of new products Compile, write and submit the dossiers. Manage communications with regulatory authorities. Contribute and/or coordinate packaging development. Review of product marketing materials to ensure conformity with product claims. Monitor and communicate regulatory requirements to ensure preparedness for upcoming submissions. Provide regular updates on the project's progress to internal stakeholders.Jouw profielAdvanced degree in life sciences (e.G., veterinary medicine, toxicology, pharmacy, chemistry, etc.) or equivalent. Previous experience in Regulatory Affairs (minimum of 1 year on drafting of regulatory documents) Experience liaising with Health Authorities In-depth knowledge of the regulatory environment and guidelines. Experience with generic medicines is an asset. Good planning and organizational skills Strong interpersonal communication skills (verbal and written). English and French required.Taalvaardigheden- Nederlands (troef)- Begrijpen : Vaardig - (C1)- Schrijven : Vaardig - (C1)- Lezen : Vaardig - (C1)- Spreken : Vaardig - (C1)