Regulatory Affairs Officer

Regulatory Affairs Consultant – Belgium & Luxembourg

Location: Belgium (supporting Belgium and Luxembourg)

Working pattern: Part-time, approximately 2.5 days per week

Contract: Freelance / Consultancy

Duration: Initial assignment of several months

Start date: ASAP, subject to confirmation

About the Opportunity

We are seeking a Regulatory Affairs Consultant to provide part-time support to a local regulatory team within the life sciences industry. This is a hands-on assignment suited to someone who can quickly integrate into an existing team and help manage ongoing regulatory activities across Belgium and Luxembourg.

The successful consultant will contribute to a range of activities covering pharmaceutical products and medical devices, with a particular focus on regulatory submissions, product lifecycle management, labelling and maintaining compliance with local requirements.

The scope will be tailored to the consultant’s background, with immediate priorities determined by the team’s current workload.

Key Responsibilities

Regulatory Submissions & Product Maintenance

• Support the preparation, submission and tracking of marketing authorisation applications, variations and renewals.
• Manage product registration updates and lifecycle records using regulatory information systems.
• Maintain regulatory databases, including XEVMPD, and ensure information remains accurate and up to date.
• Coordinate regulatory documentation and monitor submission timelines.

Product Labelling & Artwork

• Review product information documents, package leaflets and packaging materials in relevant local languages.
• Coordinate labelling updates, translations and artwork review processes.
• Check packaging components and supporting documentation using systems such as LIFT.
• Assist with the preparation and review of mock-ups for regulatory submissions.

Clinical Trials & Medical Devices

• Review clinical trial labelling and Directions for Use (DFUs), including translated materials.
• Support regulatory documentation and labelling requirements for investigational medicinal products.
• Assist with medical device registration, compliance documentation and Instructions for Use (IFU).
• Review medical device labelling for compliance with applicable local requirements.

Additional Regulatory Support

Assist with applications for Compassionate Use and Medical Need Programmes.

• Support regulatory correspondence and submissions to the relevant Belgian and Luxembourg authorities.
• Monitor local regulatory developments affecting pharmaceutical products and medical devices.
• Provide regulatory input into product quality complaints where required.

Experience & Skills

Essential

• Previous experience in Regulatory Affairs within the pharmaceutical or life sciences sector.
• Working knowledge of regulatory requirements in Belgium and/or Luxembourg.
• Practical experience in one or more of the following areas: regulatory submissions, marketing authorisation lifecycle management, product labelling or regulatory documentation.
• Ability to work autonomously, manage competing priorities and deliver accurate work with minimal supervision.
• Strong attention to detail and organisational skills.

Desirable

• Experience with Vault RIM, XEVMPD, LIFT or TVT.
• Exposure to medical device regulatory requirements or clinical trial labelling.
• Experience supporting Compassionate Use or Medical Need Programmes.
• Familiarity with the Belgian FAMHP/AFMPS and Luxembourg health authorities.
• Fluency in English and knowledge of Dutch and/or French. German would be beneficial for labelling-related activities.
• A degree in Pharmacy, Life Sciences, Biomedical Sciences or a related discipline.

Assignment Details

This is a flexible, part-time consultancy opportunity requiring approximately 50% FTE commitment. The working arrangement and exact duration will be agreed with the successful consultant.

The role will support an established local Regulatory Affairs function, with priorities and deliverables aligned to the consultant’s expertise and availability.

Please note: The assignment does not require one individual to cover every area listed. Candidates with strong practical experience in one or more of the key regulatory disciplines are encouraged to apply, particularly those available to provide support at short notice.