Regulatory Affairs Manager - Belgium & Luxembourg

Takeda Pharmaceutical Co.; Brussel Hoofdstad; On-site; EUR 66,000 - 91,000; Full time

Job summary

Takeda is seeking an experienced Regulatory Affairs professional to ensure medicinal product registrations, maintenance, and compliance across Belgium and Luxembourg. The role collaborates with local and global teams to support lifecycle management, regulatory compliance, and patient access.

You will drive regulatory submissions, labeling updates, and risk management while building strong relationships with health authorities and cross-functional partners to enable successful product

Qualifications

• Strong written and verbal communication skills.
• Experience interacting with regulatory authorities.
• Experience in Regulatory Affairs within the pharmaceutical industry.
• Fluency in Dutch, French, and English.

Responsibilities

• Plan and oversee regulatory activities across Belgium and Luxembourg for marketing authorizations, renewals, variations, safety reporting activities, and local regulatory requirements.
• Manage regulatory submissions and lifecycle activities by coordinating national phases of regulatory procedures and maintaining accurate regulatory records and archives.
• Partner with safety and cross-functional teams to support risk minimization activities, educational materials, and regulatory compliance initiatives.
• Maintain product information and labeling compliance by managing labeling updates, artwork reviews, mock-ups, and packaging materials in line with approved requirements.
• Coordinate translations and documentation updates for product information and ensure consistency and accuracy across required languages and markets.
• Build and maintain regulatory authority relationships while responding to requests, monitoring regulatory developments, and communicating relevant impacts to stakeholders.
• Support regulatory strategy and operational readiness by providing input for product launches, tenders, inspections, audits, risk management activities, and continuous process improvements.

Skills

Communication skills

Cross-functional collaboration

Analytical skills

Fluent English

Education

Science degree

Job description

Takeda is seeking an experienced Regulatory Affairs professional to ensure medicinal product registrations, maintenance, and compliance across Belgium and Luxembourg. The role collaborates with local and global teams to support lifecycle management, regulatory compliance, and patient access.

You will drive regulatory submissions, labeling updates, and risk management while building strong relationships with health authorities and cross-functional partners to enable successful product