Regulatory Affairs Manager

h3Job Description /h3h3About the Role /h3pIn 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. /ph3How You Will Contribute /h3ulliPlan and oversee regulatory activities across Belgium and Luxembourg for marketing authorizations, renewals, variations, safety reporting activities, and local regulatory requirements. /liliManage regulatory submissions and lifecycle activities by coordinating national phases of regulatory procedures and maintaining accurate regulatory records and archives. /liliPartner with safety and cross-functional teams to support risk minimization activities, educational materials, and regulatory compliance initiatives. /liliMaintain product information and labeling compliance by managing labeling updates, artwork reviews, mock-ups, and packaging materials in line with approved requirements. /liliCoordinate translations and documentation updates for product information and ensure consistency and accuracy across required languages and markets. /liliBuild and maintain regulatory authority relationships while responding to requests, monitoring regulatory developments, and communicating relevant impacts to stakeholders. /liliSupport regulatory strategy and operational readiness by providing input for product launches, tenders, inspections, audits, risk management activities, and continuous process improvements. /li /ulh3Qualifications /h3ulliUniversity degree in a scientific discipline such as Pharmacy, Medicine, Bio-engineering, or a related field. /liliAt least 5 years of experience in Regulatory Affairs within the pharmaceutical industry. /liliExperience interacting with regulatory authorities in Belgium and Luxembourg. /liliStrong written and verbal communication skills. /liliExperience working effectively in cross-functional environments and collaborating with diverse stakeholders. /liliFluency in Dutch, French, and English. /liliProficiency with digital tools and systems used to support regulatory activities. /liliStrong analytical skills, attention to detail, ability to prioritize work, adapt to change, and build effective working relationships. /li /ulh3Worker Type /h3pEmployee Worker Sub-Type Regular Time Type Full time /ph3Locations /h3pBrussels, Belgium /ph3Base Salary /h3pBase Salary Range: €66,000.00
- €90,750.00 /ppThe 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. /ph3About Takeda /h3pTakeda 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. /ppTakeda is an equal opportunity employer. /p