Regulatory Affairs Consultant
Enregistrez cette offre et organisez votre recherche
Créez un compte gratuit pour enregistrer des offres d'emploi, créer des alertes et revenir à cette liste depuis votre tableau de bord.
En continuant, vous acceptez nos Conditions d’utilisation & Politique de confidentialité.
About the Role
We are seeking an experienced Regulatory Affairs Consultant to support a leading global pharmaceutical company in Belgium. This is an excellent opportunity for a regulatory professional with strong knowledge of Belgian pharmaceutical regulations to contribute across the full product lifecycle, from submission activities to post-approval maintenance and compliance support.
Key Responsibilities
- Support pre-submission activities for National Authorisation Procedures (NAPs) in Belgium and Luxembourg, including dossier preparation and document review.
- Coordinate post-submission activities, stakeholder communications, archiving, documentation, and maintenance of regulatory databases.
- Review and manage Product Information (PI) documentation and translations for approved medicinal products.
- Support post-approval regulatory activities for both CAP and NAP products.
- Manage artwork and packaging activities, including PIL manuscript preparation and review.
- Prepare and coordinate Risk Minimisation Measures (aRMM) documentation and submissions to health authorities.
- Provide regulatory support for tender activities and market access requirements.
- Review parallel import documentation and packaging compliance requirements.
- Create and maintain Batch Inspection Records to support product release processes.
- Ensure compliance with Belgian and Luxembourg regulatory requirements and internal quality systems.
Required Experience
- University degree in Pharmacy, Life Sciences, Medical Sciences, Chemistry, or a related discipline.
- Minimum 5 years' experience within Pharmaceutical Regulatory Affairs.
- Strong knowledge of Belgian Regulatory Affairs procedures and local compliance requirements.
- Experience supporting both national and European regulatory activities.
- Hands-on experience with labelling, artwork, packaging mock-ups, SmPCs and Patient Information Leaflets.
- Ability to manage multiple regulatory projects and stakeholders simultaneously.
- Strong communication skills in English plus French or Dutch.
Preferred Experience
- Experience working in a multinational pharmaceutical environment.
- Knowledge of Belgium and Luxembourg health authority interactions.
- Familiarity with electronic document management systems (EDMS).
Why Apply?
- Work with a leading global pharmaceutical organisation.
- Long-term contract with excellent project visibility.
- Exposure to a broad range of regulatory activities across Belgium and Luxembourg.
- Hybrid working model with a mix of office and remote work.
- Opportunity to make an immediate impact within a highly regulated environment.
-
Regulatory Affairs Consultant
Il y a 4 heures
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique Oxford Global Resources Temps pleinOxford Global Resources is seeking an experienced Regulatory Affairs Consultant to support a leading global pharmaceutical company in Belgium. The role covers the full lifecycle, from submission activities to post-approval maintenance and compliance support, with a hybrid working model.Candidates should bring a university degree in a life sciences field, 5+...
-
EU Public Affairs Consultant
Il y a 22 heures
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique Milltownpartners Temps pleinMilltown Partners Our clients operate at the frontiers of innovation - we advise technology companies driving change, global investors funding the future, the giants of sport and entertainment, and influential individuals on the communications and policy challenges that define their reputations. Our work spans corporate and financial communications, policy...
-
Regulatory Risk
Il y a 4 heures
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique Intys Temps pleinIntys is seeking a consultant to support regulatory compliance projects and strengthen risk governance within Belgian organizations. You will help enhance resilience, business continuity, and compliance maturity through cross-functional initiatives and governance improvements.The role involves leading regulatory workstreams, mapping obligations, and...
-
Senior Insurance Risk
Il y a 4 heures
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique PwC Temps pleinPwC Belgium is seeking a Senior Associate to join our Assurance Insurance team. You will work on diverse client projects, contributing to risk and regulatory advisory, and helping insurers transform processes and governance.The role values collaboration, a proactive mindset, and fluency in Dutch and/or French plus English. You’ll gain exposure to...
-
Hybrid Senior Public Affairs Consultant
Il y a 4 heures
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique Andersch Ag Temps pleinFTI Consulting is seeking a Senior Consultant for their Public Affairs team focusing on the TMT sector in Brussels. The role involves advising clients on navigating public policy challenges and establishing relationships with policymakers and media.The ideal candidate has strong public affairs skills and experience working within the TMT sector. This is a...
-
Senior Consultant, Public Affairs
Il y a 4 heures
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique Andersch Ag Temps plein## Senior Consultant, Public Affairs (Tech, Media & Telecoms)Applyremote type: Hybridlocations: Brussels, Belgiumtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR251D0-TEE**Who We Are**FTI Consulting is the leading global expert firm for organizations facing crisis and transformation. We work with many of the world’s top...
-
Finance, Risk, Regulatory, Compliance
Il y a 13 heures
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique ICHEC Alumni Temps pleinSquare Management Belgium est le cabinet de référence dans le secteur financier. Avec une équipe de100 consultants experts, nous accompagnons nos clients dans leurs projets de transformation. En tant que membre du groupe Square Management, fondé en 2008 et présent en France, en Belgique et au Luxembourg, nous offrons une expertise reconnue...
-
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique Enhesa Temps pleinEHS and Sustainability Regulatory Consultant for Arabic jurisdictions Brussels Who We Are Enhesa is the leading provider of regulatory and sustainability intelligence worldwide. As a trusted partner, we empower the global business community with the insight to act today and prepare for tomorrow to create a more sustainable future - positively impacting our...
-
Manager of EU Affairs
Il y a 13 heures
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique Praxis Tech Temps pleinThis role involves managing the European Gaming and Betting Association's EU affairs, including policy and regulatory engagement. About the European Gaming and Betting Association (EGBA) The European Gaming and Betting Association (EGBA) is the leading trade association for the online gambling industry in Europe. Estimated Benefits Health Insurance Vacation...
-
Public & Government Affairs Manager EU
Il y a 8 heures
Arrondissement de Bruxelles-Capitale, Bruxelles, Belgique SMA Solar Technology AG Temps pleinTitle: Public & Government Affairs Manager EU Job Type: Full time Contract Type: Permanent Work Setup: Hybrid Required Travel: Frequent travel availability Location: Mechelen, BE, 2800 Public & Government Affairs Manager EU Shape the Future of Energy Policy in Europe Are you passionate about influencing policy, building strategic relationships, and...
