Regulatory Affairs Officer

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

Are you passionate about Regulatory Affairs and looking for a role where collaboration and impact truly matter?

Are you ready to grow within a dynamic, family-owned pharmaceutical company where quality and innovation are at the heart of everything we do?

Then Will-Pharma could be the perfect place for you!

We are currently looking for a Regulatory Affairs Officer to strengthen our Regulatory Affairs team.

YOUR KEY RESPONSIBILITIES

• Managing all artwork and text-related activities (PILs, labels, boxes, primary packaging materials) in close coordination with suppliers, project managers and internal stakeholders.
• Coordinating the proofreading process for mock-ups and ensuring accuracy, consistency and compliance.
• Updating and correcting product information documents, including SmPCs, labelling and PILs, in line with applicable changes and QRD guidelines prior to submission.
• Organising, coordinating and prioritising regulatory activities related to linguistic translations and reviews.
• Preparing, compiling and reviewing the regulatory sections of registration dossiers, in collaboration with the Regulatory Affairs Manager and, where required, external partners, in CTD and eCTD format.
• Preparing and submitting minor variations and notifications to support regulatory activities.
• Preparing and submitting notifications for food supplements. Reviewing and approving promotional materials related to food supplements and cosmetics, in accordance with the relevant legislation.
• Supporting the lifecycle management of the Will-Pharma product portfolio by applying regulatory processes and procedures and ensuring appropriate tracking of changes.
• Keeping up to date with current European and national legislation relating to medicinal products, medical devices, food supplements and cosmetics.

WHAT YOU BRING TO THE TEAM

We are looking for someone who combines regulatory expertise with strong organisational skills and a collaborative mindset. You ideally have:

• A scientific degree.
• Practical experience in Regulatory Affairs, particularly in artwork and text management.
• Good knowledge of European regulatory requirements, mainly within the Benelux region.
• Excellent organisational and interpersonal skills, with strong written and verbal communication abilities.
• A structured, process-oriented approach and strong attention to detail.
• Good IT skills and the ability to quickly learn new software tools.
• A good understanding of regulatory tracking databases, MS Word, MS Excel and eCTD.
• Strong analytical and evaluation skills.
• Fluency in English, Dutch and French.

WHAT WE OFFER

At Will-Pharma, you will join a medium family-owned company where people work together with passion, dedication and respect. We value quality, agility, personal relationships, collaboration and customer focus. We offer:

• A full-time, permanent position with a day schedule from Monday to Friday.
• A challenging and varied role with opportunities for personal growth and the development of in-depth product knowledge.
• The opportunity to develop yourself, take ownership and grow within a supportive environment.
• A competitive remuneration package, including fixed and variable components.
• Additional benefits such as hospitalisation insurance, group insurance and other fringe benefits.
• The opportunity to work in a wellbeing-oriented organisation, with initiatives designed to help employees stay healthy and continuously improve their wellbeing.
• A pleasant, diverse and multicultural working environment where collaboration and inclusion are highly valued.