Regulatory Affairs Senior Manager Benelux

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Regulatory Affairs Senior Manager Benelux

Location: Ghent, BE, 9050

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

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)

• 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)

• 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.