Regulatory Affairs Manager
il y a 2 semaines
Great new 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 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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Senior Director, Regulatory Affairs
il y a 7 jours
East Flanders, Belgique WhatJobs Temps pleinSenior Director, Regulatory Affairs - CMC, Regulatory Operations & Lifecycle Management Join to apply for the Senior Director, Regulatory Affairs - CMC, Regulatory Operations & Lifecycle Management role at Perrigo Company plc Get AI-powered advice on this job and more exclusive features. At Perrigo, we are driven by our mission to Makes Lives Better Through...
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Regulatory Affairs and Pharmacovigilance Manager
il y a 2 semaines
East Flanders, Belgique NonStop Consulting Temps pleinOur client, an established but also growing company in the pharmaceutical sector, is looking for a Regulatory Affairs and Pharmacovigilance Manager. This organization provides a unique opportunity to work with diverse products spanning medicines, medical devices, food supplements, and cosmetics, with focus on the pharmaceutical products, but this will give...
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Regulatory Affairs and Pharmacovigilance Manager
il y a 2 semaines
East Flanders, Belgique NonStop Consulting Temps pleinOur client, an established but also growing company in the pharmaceutical sector, is looking for a Regulatory Affairs and Pharmacovigilance Manager. This organization provides a unique opportunity to work with diverse products spanning medicines, medical devices, food supplements, and cosmetics, with focus on the pharmaceutical products, but this will give...
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Associate Director
il y a 2 semaines
East Flanders, Belgique WhatJobs Temps pleinAssociate Director - CMC Regulatory Affairs Join to apply for the Associate Director - CMC Regulatory Affairs role at Perrigo Company plc Description Overview As Associate Director, you will lead the development and execution of cutting-edge Chemistry, Manufacturing & Control (CMC) strategies, ensuring the highest standards of regulatory excellence across...
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Medical Writer
il y a 1 jour
Flanders, Belgique Actalent Temps pleinIn this hands‐on role, you'll be at the heart of Post‐Market Clinical Follow‐Up (PMCF) and Post‐Market Surveillance (PMS) activities—driving best practices, ensuring compliance, and shaping smarter, safer medical technologies. You'll draft and maintain PMCF plans and evaluation reports, align findings across clinical evaluations, and contribute to...
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Therapeutic Area Lead
il y a 1 semaine
Flanders, Belgique CareForce One Temps pleinWe have a very interesting opportunity for a Therapeutic Area Lead (MD) to join a biotech company with an impressive pipeline and eminent launches. You will play a key role in shaping the medical and scientific direction of the local organization and lead the team of Medical Affairs Professionals. An MD degree and experience in a Medical Affairs Department...
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Portfolio Senior Manager
il y a 5 jours
Flanders, Belgique PeakSeek Temps pleinOur client, a leading infrastructure and renewables fund is looking for strong additions to their Asset Management / Portfolio teamResponsibilities Manage the full lifecycle performance of infrastructure and renewable energy assets, including monitoring KPIs, budgets, contracts, and risk exposure.Lead financial and operational reporting for investors,...
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Quality Assurance Specialist
il y a 3 jours
West Flanders, Belgique Vivid Resourcing Temps plein✨ Job Opportunity: Quality Specialist (Flanders Region) Location: Flanders Region (Hybrid possible) Employment: Full-time Languages: English Salary : €80,000 About the Role We are looking for a detail-oriented Food Compliance & Labelling Specialist to support our product portfolio across the Benelux market. In this role, you will ensure that our products...
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Quality Assurance Specialist
il y a 3 semaines
West Flanders, Belgique Vivid Resourcing Temps plein✨ Job Opportunity: Quality Specialist (Flanders Region)Location: Flanders Region (Hybrid possible)Employment: Full-time Languages: EnglishSalary: €80,000About the RoleWe are looking for a detail-oriented Food Compliance & Labelling Specialist to support our product portfolio across the Benelux market. In this role, you will ensure that our products meet...
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Chief Technology Officer
il y a 3 semaines
East Flanders, Belgique WhatJobs Temps pleinThe Chief Technology Officer (CTO) leads the Development team and oversees all IT initiatives, ensuring the successful delivery of high-quality software solutions, IT systems, and processes. This role ensures technological excellence, operational stability, and the achievement of strategic development goals. KEY RESPONSIBILITIES Define and execute a clear...
