Regulatory Affairs Manager

Kintiga; Oost-Vlaanderen; Hybride; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

End-of-year 13th month

Mobility budget

32 days of leave (20 legal + 12 ADV)

Résumé du poste

Kintiga is seeking a Regulatory Affairs professional to lead BeNeLux regulatory activities, RIP, and local pharmacovigilance with QPPV responsibilities. The role spans regulatory, medical information, and market access tasks across BeNeLux with a strong emphasis on stakeholder engagement.

The position offers hybrid work with only one day per week in Ghent (Tuesday) and requires fluency in Dutch, French and English. A Master’s/PhD in science and prior pharma/consulting experience are essential.

Qualifications

• Master's or PhD in science or related field and strong regulatory background.
• Experience in BeNeLux regulatory management and EMA/local regulatory requirements.
• Fluency in Dutch, French and English; native Dutch or French preferred.
• Experience with RIP activities and local GVP is a plus.

Responsabilités

• Manage BeNeLux regulatory activities to obtain marketing authorizations.
• Support or manage RIP (Responsible for Information and Publicity).
• Oversee local pharmacovigilance activities and contribute to QPPV tasks.
• Contribute to reimbursement files through medical writing and RWE.
• Contribute to Medical Affairs projects and stakeholder interactions.
• Handle medical information activities and respond to enquiries.

Connaissances

Regulatory affairs

Project management

Stakeholder management

Dutch language

French language

English language

Formation

Master's degree or PhD in biomedical/scientific field

Outils

Regulatory submission tools

Description du poste

We are Kintiga, a pan-European specialist that partners with ambitious health technology developers through the complex journey to achieve successful patient access across Europe, with our tailored approach, global perspective and local expertise. Kintiga unites three companies: MAP Patient Access (UK), AxTalis (Benelux), and SKC Consulting (Germany).

We’re looking for a Regulatory Affairs professional with a strong scientific background (Master’s/PhD) and solid experience within the pharmaceutical industry or consulting environment. You’ll bring proven knowledge of local and EMA regulatory requirements, with added value if you’ve previously supported RIP activities or worked with EU/Local GVP. Fluency in Dutch, French and English is essential, with preference for native Dutch or French speakers.

You’ll thrive in a role that spans BeNeLux regulatory management, pharmacovigilance (local QPPV), medical information, and contributions to market access and medical affairs projects. We’re looking for someone who is accountable, entrepreneurial, highly organised, and able to manage multiple priorities in a complex environment. A strong networker who can influence stakeholders, communicate clearly, and is passionate about shaping the value story of healthcare solutions will excel here.

This role would be suitable for an experienced Officer ready to take that next step. You will be required to work only one day per week (Tuesday) in the office in Ghent.

Key Responsibilities

• Management of local (BeNeLux) regulatory activities to obtain marketing authorizations for pharmaceutical products
• Management and/or support of activities as Responsible for Information and Publicity (RIP)
• Management of local (BeNeLux) pharmacovigilance activities including input to safety reports and management of ICSR as local QPPV
• Contribution to reimbursement files by medical writing and/or budget impact analysis and RWE collection.
• Contribution to Medical Affairs projects such as development of patient journeys, slide decks for training, patient, HCP and marketing materials.
• Management of stakeholder interactions including advisory boards and scientific presentations.
• Involvement in medical information activities at local and global level. This entails replying to medical enquiries and relevant reporting of adverse events, technical complaints or special situations.
• Management of field market access research.
• Master/PhD degree in science (Biomedical sciences, Biotechnology, Pharmaceutical sciences, Drug Development, Medical Doctor, Biosciences), or equal through experience gained in Pharmaceutical Industry.
• Languages: Dutch/French/English (by preference native French or Dutch).
• Previous experience in a pharmaceutical company or an agency providing consulting/clinical services to pharmaceutical industry is required.
• Having the technical regulatory knowledge of local/EMA regulatory requirements is required.
• Having previous exposure to RIP activities is a clear asset.
• First experience with local / EU GVP requirements is valuable.
• Strong interest to develop market access and medical affairs skills is required.
• Excellent stress and time management and ability to handle priorities and deadlines.
• Strong networker with ability to influence internal and external stakeholders.
• Team player - accountable and entrepreneurial.
• Dynamic and ambitious professional.
• Hands-on strategic & innovative thinker.
• Able to manage multiple tasks in a complex environment.
• Passionate about creating and communicating the value story of healthcare solutions.
• Detail oriented.

Competitive Salary (dependent on experience)

Extensive benefit programme, including meal vouchers, end-of-year 13th month & mobility budget

32 days of leave (20 legal days and 12 ADV work time reduction days)

Exposure to an international work environment with cross-border project responsibilities

Hybrid environment – only 1 day per week in the office (Ghent Office on a Tuesday)

Flexible working – to help maintain a better work/life balance.

We bring together diverse backgrounds and expertise, and our team is dynamic, solutions-focused, and committed to delivering excellence. If you are a results-driven professional looking for an opportunity to help shape the future of a growing European business, we would love to hear from you!

• This role is open to full-time applicants only.
• Unfortunately, we are unable to sponsor candidates for this role.