Regulatory Affairs Manager

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

Job summary

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.

Responsibilities

• 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.

Job description

Job Description

About The Role

In this role, you will help ensure that medicinal products are registered, maintained, and compliant across Belgium and Luxembourg. You will be part of an international regulatory affairs organization, working closely with local and global colleagues to support product lifecycle management, regulatory compliance, and business objectives. You will serve as a key regulatory contact for internal and external stakeholders, including health authorities, providing expertise on regulatory matters and helping align local and global requirements. Your work will contribute to successful product registrations, launches, and ongoing compliance while supporting accurate product information and regulatory documentation. You will play a key role in maintaining strong relationships with regulatory authorities and collaborating across functions to support business priorities, regulatory excellence, and patient access to medicines.

How You Will Contribute

• 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.

Qualifications

• University degree in a scientific discipline such as Pharmacy, Medicine, Bio-engineering, or a related field.
• At least 5 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Experience interacting with regulatory authorities in Belgium and Luxembourg.
• Strong written and verbal communication skills.
• Experience working effectively in cross-functional environments and collaborating with diverse stakeholders.
• Fluency in Dutch, French, and English.
• Proficiency with digital tools and systems used to support regulatory activities.
• Strong analytical skills, attention to detail, ability to prioritize work, adapt to change, and build effective working relationships.

Locations

Brussels, Belgium

Base Salary Range

€66,000.00 - €90,750.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Benefits

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time