BeLux Regulatory Affairs Officer – Part-Time, Labelling

Excelya; Brussel Hoofdstad; Presencial; EUR 30 000 - 52 000; Tempo parcial

Resumo da oferta

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

Key tasks include maintaining Vault RIM databases, managing translations, and coordinating documentation across Dutch, French, and German. Fluency in English is required; French/Dutch are a plus.

Qualificações

• Experience in regulatory submissions for pharma/medical devices.
• Knowledge of Belgian and Luxembourg requirements.
• Ability to work autonomously with minimal onboarding.
• Strong organizational skills and ability to manage priorities.
• Fluency in English; French and/or Dutch is advantageous.

Responsabilidades

• Prepare, submit, and track marketing authorization applications and variations.
• Manage registrations and lifecycle activities within Vault RIM.
• Maintain regulatory databases and ensure data accuracy.
• Coordinate regulatory documentation and translations (Dutch, French, German).
• Support labelling changes, artwork reviews, and submission mock-ups.
• Provide regulatory support for medical devices and COVID-19 related programs.

Conhecimentos

Regulatory Submissions

Labelling activities

BeLux regulation

Autonomous work

Attention to detail

Multitasking

English + FR/Dutch

Formação académica

Bachelor or Master in Life Sciences

Ferramentas

Vault RIM

XEVMPD

LIFT

TVT

Descrição da oferta de emprego

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

Key tasks include maintaining Vault RIM databases, managing translations, and coordinating documentation across Dutch, French, and German. Fluency in English is required; French/Dutch are a plus.