Regulatory Affairs Consultant

Oxford Global Resources; Brussel Hoofdstad; Ibrido; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Oxford 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+ years in Regulatory Affairs, and strong knowledge of Belgian procedures.

Competenze

• 5+ years of experience in Pharmaceutical Regulatory Affairs.
• Strong knowledge of Belgian regulatory procedures and local compliance.
• Experience supporting national and European regulatory activities.
• Hands-on experience with labeling, artwork, packaging mock-ups, SmPCs and PI leaflets.
• Ability to manage multiple regulatory projects and stakeholders simultaneously.
• Strong communication in English plus French or Dutch.

Mansioni

• Support pre-submission activities for National Authorisation Procedures in Belgium and Luxembourg.
• Coordinate post-submission activities, communications, archiving and regulatory databases.
• Review and manage Product Information documentation and translations for approved products.
• Support post-approval regulatory activities for CAP and NAP products.
• Manage artwork and packaging activities, PIL manuscript preparation and review.
• Prepare and coordinate Risk Minimisation Measures (aRMM) 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.

Conoscenze

Project management

Stakeholder management

English & French/Dutch

Regulatory affairs knowledge

Formazione

University degree in Pharmacy/Life Sciences/Medical Sciences/Chemistry

Descrizione del lavoro

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.