Regulatory Affairs Manager

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.

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