Regulatory Affairs Manager - Belgium & Luxembourg

Takeda; Brussel Hoofdstad; Sur place; EUR 66 000 - 91 000; Plein temps

Résumé du poste

Takeda in Brussels, Belgium, seeks an experienced Regulatory Affairs professional to ensure medicines are registered, maintained and compliant across Belgium and Luxembourg, working with local and global colleagues on lifecycle management.

You will oversee regulatory submissions, labeling updates, translations and documentation, and build strong relationships with health authorities to support launches, risk management and patient access.

Qualifications

• University degree in a scientific field.
• At least 5 years of experience in Regulatory Affairs.
• Experience interacting with regulatory authorities in Belgium and Luxembourg.
• Strong written and verbal communication skills.
• Fluency in Dutch, French, and English.

Responsabilités

• Plan and oversee regulatory activities across Belgium and Luxembourg for marketing authorizations, renewals, variations, safety reporting, and local regulatory requirements.
• Manage regulatory submissions and lifecycle activities, coordinating national phases and maintaining regulatory records.
• Partner with safety and cross-functional teams to support regulatory compliance initiatives.
• Maintain product information and labeling compliance, including updates, artwork reviews, and packaging materials.
• Coordinate translations and documentation updates for required languages and markets.
• Build and maintain regulatory authority relationships and monitor regulatory developments.
• Support regulatory strategy and operational readiness for launches, tenders, inspections, audits, and continuous improvements.

Description du poste

Takeda in Brussels, Belgium, seeks an experienced Regulatory Affairs professional to ensure medicines are registered, maintained and compliant across Belgium and Luxembourg, working with local and global colleagues on lifecycle management.

You will oversee regulatory submissions, labeling updates, translations and documentation, and build strong relationships with health authorities to support launches, risk management and patient access.