Regulatory Affairs Manager

Kintiga; Gent; Hybride; EUR 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

End-of-year 13th month

Mobility budget

32 days of leave

Résumé du poste

Kintiga is seeking an experienced Regulatory Affairs professional to oversee BeNeLux regulatory activities, pharmacovigilance, and medical affairs contributions across Europe. The role emphasizes a strong scientific background, multi-language fluency, and ability to manage multiple priorities in a complex environment.

You will work in a hybrid setup with one day per week in Ghent, collaborating with cross-functional teams and influencing stakeholders to shape the value story of healthcare

Qualifications

• Master/PhD in science required.
• Fluency in Dutch, French and English (prefer native Dutch or French).
• Experience in a pharmaceutical company or agency providing consulting/services to pharma is required.
• Strong knowledge of local and EMA regulatory requirements.

Responsabilités

• Manage BeNeLux regulatory activities to obtain marketing authorizations for products.
• Support RIP activities (Responsible for Information & Publicity).
• Oversee local pharmacovigilance activities and contribute to safety reports as local QPPV.
• Contribute to reimbursement files through medical writing and budget impact analysis, and RWE collection.

Connaissances

Regulatory affairs

Stakeholder management

Project management

Medical writing

Formation

Master’s/PhD in biomedical sciences

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 and 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.
• No agencies please.
• Unfortunately, we are unable to sponsor candidates for this role.