Regulatory Affairs Officer (Pharma)

About the role

Will-Pharma is seeking a motivated Regulatory Affairs Officer to join its dynamic, family‑owned pharmaceutical team. You will support the lifecycle management of a diverse product portfolio and ensure compliance with European and national regulations across medicines, medical devices, food supplements, and cosmetics.

Key responsibilities

• Manage artwork and text activities for product labeling, packaging, and patient information leaflets, coordinating with suppliers and internal stakeholders.
• Coordinate proofreading of mock‑ups, guaranteeing accuracy, consistency, and regulatory compliance.
• Update product information documents (SmPCs, labeling, PILs) according to QRD guidelines before submission.
• Organise and prioritise regulatory translation activities and reviews.
• Prepare and review regulatory sections of registration dossiers in CTD/eCTD format, collaborating with the Regulatory Affairs Manager and external partners.
• Submit minor variations, notifications, and food‑supplement notifications.
• Review and approve promotional materials for food supplements and cosmetics in line with legislation.
• Support lifecycle management by applying regulatory processes, tracking changes, and staying current with European and national legislation.

Required profile

• Scientific degree with practical regulatory affairs experience, especially in artwork and text management.
• Strong knowledge of European regulatory requirements, primarily in the Benelux region.
• Excellent organisational, interpersonal, and communication skills in English, Dutch, and French.
• Detail‑oriented, process‑driven, and capable of working collaboratively.

Required skills

• Proficiency with MS Word
• Proficiency with MS Excel
• Experience using eCTD submission tools
• Familiarity with regulatory tracking databases

What we offer

• Opportunity to work in a medium‑sized, family‑owned company that values quality, agility, and innovation.
• Collaborative environment with room for professional growth.