Regulatory Affairs Manager

BEL - 9090 Takeda Belgium NV; 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

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.

Worker Type

Employee Worker Sub-Type Regular Time Type Full time

Locations

Brussels, Belgium

Base Salary

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.

About Takeda

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer.