Regulatory Affairs Senior Manager Benelux

Description Overview

The Regulatory Affairs Senior Manager Benelux is responsible for leading Regulatory Affairs activities across Belgium, the Netherlands, and Luxembourg, ensuring regulatory compliance throughout the product lifecycle and in all business operations.

The role serves as the legally designated Responsible Person for Information & Publicity (RIP) for Belgium and Local Contact Person for Vigilance (LCPV) for the Benelux region. The incumbent provides strategic regulatory and vigilance leadership, ensuring compliance with applicable regulations, safeguarding patient safety, supporting business growth, and maintaining effective relationships with health authorities and industry stakeholders.

Scope of the Role

Regulatory Leadership

•    Ensures Regulatory Affairs activities are conducted in accordance with applicable EU, Belgian, Dutch, Luxembourg, and company requirements.
•    Oversees the preparation, submission, approval, maintenance, and lifecycle management of regulatory dossiers, permits, licenses, certificates, authorizations, and notifications.
•    Provides strategic regulatory guidance to support new product introductions, lifecycle management activities, product claims, labeling updates, and market expansion initiatives.
•    Monitors changes in the regulatory environment and advises management regarding emerging regulations, risks, and opportunities.
•    Supports business continuity by ensuring regulatory compliance throughout all commercial and operational activities.

Responsible Person Information & Publicity (Belgium)
As the designated RIP:

•    Ensure compliance of all medicinal product advertising and promotional activities with Belgian legislation and FAMHP requirements prior to dissemination.
•    Review and provide final approval for promotional and advertising materials intended for healthcare professionals and/or consumers.
•    Verify compliance of product information, SmPCs, package leaflets, and associated translations.
•    Establish and maintain internal procedures governing approval of promotional materials and regulatory communications.
•    Ensure compliance with regulations governing medical samples, sponsorships, benefits, and interactions with healthcare professionals.
•    Oversee the training and qualification of medical representatives and other employees involved in promotional activities.

Local Contact Person for Vigilance (Benelux)
As the designated Local Contact Person for Vigilance (LCPV):

•    Acts as the primary local contact for pharmacovigilance and product safety matters within Belgium, the Netherlands, and Luxembourg.
•    Ensures local vigilance activities comply with applicable EU Good Pharmacovigilance Practices (GVP), local legislation, and company requirements.
•    Supports implementation and maintenance of local pharmacovigilance systems, procedures, documentation, and inspection readiness.
•    Facilitates communication between Global Patient Safety, Regulatory Affairs, Medical Affairs, Quality, Consumer Services, Commercial functions, and local health authorities.
•    Supports the management and escalation of adverse events, special situations, product quality complaints with safety implications, and emerging safety concerns.
•    Maintains oversight of local regulatory and vigilance commitments and supports risk minimization activities and safety communications.
•    Acts as local representative during pharmacovigilance inspections, audits, authority requests, and safety-related inquiries.
•    Ensures timely implementation and effectiveness of vigilance-related CAPAs arising from audits and inspections.
Health Authority & External Affairs relationship
•    Establishes and maintains effective relationships with relevant health authorities, including FAMHP/FAGG, CBG-MEB, IGJ, and Luxembourg competent authorities.
•    Represents the company during regulatory inspections, audits, authority meetings, and industry forums.

Business Partnership
•    Partner with Commercial, Marketing, Medical, Quality, Safety, Supply Chain, Innovation, and Legal functions to support business objectives.

Leadership & People Management
•    Leads, develops, and coaches a team of Regulatory Affairs professionals.
•   Escalate significant regulatory or vigilance compliance risks to senior management.

Experience Required

Education
•    University Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Medicine, or equivalent scientific discipline.
•    Pharmacist qualification preferred.
•    Eligible to act as Responsible Person for Information & Publicity in Belgium, and to act as LCP for Benelux countries. Recognized approval or ability to obtain such approval.
Experience
•    Minimum 6 years of Regulatory Affairs experience within pharmaceutical, consumer healthcare, medical device, or life sciences industries.
•    Minimum 2 years of supervisory or people leadership experience.
•    Proven experience in regulatory submissions, product lifecycle management, and health authority interactions.
•    Experience reviewing promotional materials and managing compliance activities.
•    Experience supporting pharmacovigilance activities, inspections, or audits preferred.
Knowledge & Skills
•    Strong knowledge of EU pharmaceutical legislation and Benelux regulatory requirements.
•    Thorough understanding of Belgian medicinal product advertising and promotional compliance requirements.
•    Good understanding of EU Good Pharmacovigilance Practices (GVP) and local vigilance requirements.
•    Strong stakeholder management, communication, and influencing skills.
•    Ability to manage multiple priorities in a matrix organization.
•    Fluent in English and Dutch; French is highly desirable. German an asset.