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 Authorities Ensuring continued maintenance of Marketing Authorizations. Life cycle management of marketed products New registrations Manage 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 market Support cross-functional PV requests Serve 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) qualification Demonstrated 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 risks Mother 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 perform Reside in Belgium OFFER: 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 benefits CONTACT: If this sounds like the challenge for you, I would love to hear from you Please 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 Manager/Director of Regulatory Affairs
il y a 2 semaines
Région Flamande, Belgique CareForce One Temps pleinGreat 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. You will be the key partner to the local organization for all Regulatory (RA) and some Pharmacovigilance (PV) / Patient Safety matters. The role reports into...
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Risk Management
il y a 1 semaine
Région Flamande, Belgique Planet Pharma Temps pleinTitle: Functional Project Manager (Pharmacology &Toxicology and Bioanalytics) Company: Global Leading CRO/Biotech Type: 8 months contract - full-time (40 hours per week) Track and manage internal and external vendor activities, ensuring delivery against timelines, budgets, and quality expectations. Coordinate sample shipments and specialty lab data...
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Medical Writer
il y a 2 semaines
Région Flamande, 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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Senior Medical Writer
il y a 2 semaines
Région Flamande, 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...
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Functional Project Manager
il y a 1 semaine
Région Flamande, Belgique Planet Pharma Temps pleinTitle: Functional Project Manager (Pharmacology &Toxicology and Bioanalytics) Company: Global Leading CRO/Biotech Location: Hybrid - Flemish Region, Belgium Type: 8 months contract - full-time (40 hours per week) Main Responsibilities Track and manage internal and external vendor activities, ensuring delivery against timelines, budgets, and quality...
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Therapeutic Area Lead
il y a 6 jours
Région Flamande, 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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Therapeutic Area Lead
il y a 1 semaine
Région Flamande, 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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Project Consultant Industrie
il y a 1 semaine
Région Flamande, Belgique USG Professionals Belgium Temps pleinDe wereld van de life science industrie beweegt snel. Daarom bouwen we vandaag al aan een netwerk van science professionals die klaarstaan voor hun volgende uitdaging zodra die zich aandient. Deze vacature is geen klassieke functie, maar vooral een uitnodiging om elkaar nu al te leren kennen . Als preferred supplier bij veel toonaangevende bedrijven...
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Portfolio Senior Manager
il y a 2 semaines
Région Flamande, Belgique PeakSeek Temps pleinOur client, a leading infrastructure and renewables fund is looking for strong additions to their Asset Management / Portfolio team Responsibilities 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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Senior Quality Assurance Engineer
il y a 2 jours
Région Flamande, Belgique Vivid Resourcing Temps plein 80.000 €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 meet...
