Regulatory Affairs Manager

Patient Access Collaborative

Regulatory Affairs Manager in pharmaceutical industry overseeing local regulatory management and pharmacovigilance activities in BeNeLux. Engaging in medical information and market access projects within a hybrid work environment.

Posted 6/14/2026full-timeGhent • 🇧🇪 BelgiumMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Competitive Salary (dependent on experience)
Extensive benefit programme
Company-wide meet-ups
Exposure to an international work environment with cross-border project responsibilities.
Flexible working – to help maintain a better work/life balance.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmacovigilancemedical writingbudget impact analysisreal-world evidence (RWE) collectionstakeholder managementmarket access researchlocal regulatory knowledgeEMA regulatory requirementsGVP requirements

Soft Skills

stress managementtime managementprioritizationinfluencingnetworkingteam playeraccountabilityentrepreneurial mindset

Certifications

Master's degreePhD