BeLux Regulatory Affairs Specialist | Part-Time

Excelya; Brussel Hoofdstad; On-site; EUR 40,000 - 70,000; Part time

Job summary

Excelya seeks an experienced Regulatory Affairs Officer to provide temporary, part-time regulatory support for BeLux. The consultant will assist with submissions, lifecycle management, labelling, and compliance for pharma products and medical devices.

The role requires autonomy, strong organization, and ability to manage multiple priorities, while coordinating translations in Dutch, French, and German. Fluency in English plus French/Dutch is preferred.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biomedical Sciences, or a related field.
• Previous Regulatory Affairs experience within the pharmaceutical industry.
• Good knowledge of Belgian and Luxembourg regulatory requirements.
• Hands-on experience with regulatory submissions, lifecycle management, and/or labelling activities.
• Ability to work autonomously with minimal onboarding.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.
• Fluency in English; French and/or Dutch preferred; German advantageous.

Responsibilities

• Prepare, submit, and track marketing authorization applications, variations, and renewals.
• Manage product registrations and lifecycle activities within Vault RIM.
• Maintain regulatory databases, including XEVMPD updates, ensuring data accuracy and compliance.
• Coordinate, maintain, and archive regulatory documentation.
• Ensure compliance with local regulatory requirements and submission timelines.
• Coordinate and review regulatory labelling documents (SmPCs, package leaflets, and product labels) and manage translations in Dutch, French, and German.
• Support labelling change requests, artwork reviews, approvals, and submission mock-ups.
• Support clinical trial labelling activities, including review of labels, Directions for Use (DFUs), and translated materials.
• Provide regulatory support for medical devices, including product registrations, documentation maintenance, IFU translations, and labelling compliance.
• Contribute to Compassionate Use and Medical Need Programs, regulatory intelligence activities, and quality/compliance support.

Skills

Regulatory submissions

Regulatory lifecycle management

Labelling activities

Project coordination

Attention to detail

Prioritization

English fluency

French/Dutch language skills

Education

Life Sciences/Pharmacy degree

Tools

Vault RIM

XEVMPD

LIFT

TVT

Job description

Excelya seeks an experienced Regulatory Affairs Officer to provide temporary, part-time regulatory support for BeLux. The consultant will assist with submissions, lifecycle management, labelling, and compliance for pharma products and medical devices.

The role requires autonomy, strong organization, and ability to manage multiple priorities, while coordinating translations in Dutch, French, and German. Fluency in English plus French/Dutch is preferred.