Regulatory Affairs Specialist: Dossier & Artwork Lead

Will Pharma; Waver; Sur place; EUR 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

Hospitalisation insurance

Group insurance

Fringe benefits

Wellbeing program

Diverse and multicultural environment

Résumé du poste

Will-Pharma, a dynamic family-owned pharmaceutical company, seeks a Regulatory Affairs Officer to strengthen the Regulatory Affairs team. You will manage artwork/text activities, coordinate translations, and help prepare CTD/eCTD registration dossiers. Strong regulatory knowledge and attention to detail are essential.

Fluency in English, Dutch and French, plus experience in artwork/text management, will support collaboration with suppliers and stakeholders across the Benelux region.

Qualifications

• A scientific degree required.
• Experience in Regulatory Affairs, especially artwork and text management.
• Knowledge of European regulatory requirements, particularly Benelux.

Responsabilités

• Manage artwork and text activities (PILs, labels, packaging) with suppliers and stakeholders.
• Coordinate proofreading for mock-ups and ensure accuracy and compliance.
• Update product information: SmPCs, labelling, PILs per changes and QRD guidelines.
• Organise linguistic translations and reviews for regulatory activities.
• Prepare and review regulatory sections of CTD/eCTD registration dossiers with AI/partners.
• Submit minor variations and notifications for regulatory activities.
• Review and approve promotional materials for food supplements and cosmetics per legislation.
• Support lifecycle management and track regulatory changes for Will-Pharma portfolio.
• Stay updated on European and national laws for medicines, devices, supplements and cosmetics.

Connaissances

Regulatory affairs

Artwork management

Document control

Regulatory tracking databases

MS Word

MS Excel

eCTD

English

Dutch

French

Formation

Science degree

Outils

MS Word

MS Excel

eCTD

Regulatory databases

Description du poste

Will-Pharma, a dynamic family-owned pharmaceutical company, seeks a Regulatory Affairs Officer to strengthen the Regulatory Affairs team. You will manage artwork/text activities, coordinate translations, and help prepare CTD/eCTD registration dossiers. Strong regulatory knowledge and attention to detail are essential.

Fluency in English, Dutch and French, plus experience in artwork/text management, will support collaboration with suppliers and stakeholders across the Benelux region.