BeLux Regulatory Affairs Officer (Part-Time)

Excelya Group; Brussel Hoofdstad; On-site; EUR 34,000 - 48,000; Part time

Job summary

Excelya is seeking an experienced Regulatory Affairs Officer to provide temporary, part-time support for BeLux regulatory activities. The role covers submissions, lifecycle management, labeling, and compliance for pharma products and medical devices.

Ideal candidates have a life sciences degree, hands-on regulatory experience in the pharma sector, and fluency in English (French/Dutch advantageous). Be part of a collaborative, growth-oriented team at Excelya.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biomedical Sciences, or related field.
• Previous Regulatory Affairs experience in the pharmaceutical industry.
• Good knowledge of Belgian and Luxembourg regulatory requirements.
• Hands-on experience with regulatory submissions, lifecycle management, and labelling.
• Ability to work autonomously with minimal onboarding.
• Strong organizational skills and attention to detail.
• Experience with regulatory tools such as Vault RIM, XEVMPD, LIFT, TVT is an asset.
• Knowledge of medical device regulations and clinical trial labelling is desirable.
• Experience with Compassionate Use and Medical Need Programs is a plus.
• Fluency in English; French/Dutch are 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.
• Coordinate, maintain, and archive regulatory documentation.
• Ensure compliance with local regulatory requirements and submission timelines; coordinate and review labelling documents and translations.
• Support labelling changes, artwork reviews, and submission mock-ups.
• Support clinical trial labelling activities, including label reviews and DFUs.
• Provide regulatory support for medical devices, including registrations and IFU translations.
• Contribute to Compassionate Use and Medical Need Programs, regulatory intelligence, and quality/compliance.

Skills

Regulatory submissions

Labelling activities

Regulatory compliance

Autonomous working

Regulatory tools Vault RIM

Education

Bachelor's or Master's in Life Sciences/Pharmacy

Tools

Vault RIM

XEVMPD

LIFT

TVT

Job description

Excelya is seeking an experienced Regulatory Affairs Officer to provide temporary, part-time support for BeLux regulatory activities. The role covers submissions, lifecycle management, labeling, and compliance for pharma products and medical devices.

Ideal candidates have a life sciences degree, hands-on regulatory experience in the pharma sector, and fluency in English (French/Dutch advantageous). Be part of a collaborative, growth-oriented team at Excelya.