Regulatory Affairs Manager

il y a 3 semaines


Brussels, Belgique CareForce One Temps plein

Great opportunity for a Regulatory Affairs Manager to join the Belgian affiliate of a mid-size pharmaceutical company that recently acquired new molecules, mainly Orphan Drugs / Oncology.JOB SCOPE:You will be the key partner to the local organization for all Regulatory (RA) and some Pharmacovigilance (PV) / Patient Safety matters. This is a great opportunity to combine both areas of expertise while driving meaningful impact.The role reports into Regulatory Europe and works in close alignment with the Patient Safety Center Manager, as well as other internal and global partners across Medical Affairs, QA, Market Access, Business Units and more.MAIN RESPONSIBILITIES:Oversee essential regulatory activities, including interactions with Health AuthoritiesEnsuring continued maintenance of Marketing Authorizations.Life cycle management of marketed productsNew registrationsManage potential Early Access Programs.Act as the main point of contact for the Health Authorities to help nurture strong and proactive relationships.Ensure proper handling of safety cases from the Belgian marketSupport cross-functional PV requestsServe as the nominated PV contact toward the Belgian Health Authority.PROFILE:A master's degree in Pharmacy or qualification as a Medical Doctor (required)Willingness to obtain RIP (Responsible Person for Information & Publicity) qualificationDemonstrated experience in pharmaceutical regulatory affairs with good knowledge of local regulatory requirements (experience with EU GVP is valuable)Strategic mindset and ability to understand business needs and manage risksMother tongue Dutch and excellent English skills are necessary (French is a plus)You are a standout colleague with a high level of dedication and a strong willingness to performReside in BelgiumOFFER:A diverse, inclusive, and innovative environment where different perspectives are valued.The company thrives on curiosity, creativity, and continuous growth.Market-competitive salary package and fringe benefitsCONTACT:If this sounds like the challenge for you, I would love to hear from youPlease don't hesitate to apply here or to get in touch with Katleen Broeckhoven at katleen@careforceone.be (please include CV)


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