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.