Regulatory Affairs Consultant
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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.
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