Regulatory Affairs Manager

pWe 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). /ppWe’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. /ppYou’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. /ppbThis 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. /b /ph3Key Responsibilities /h3ulliManagement of local (BeNeLux) regulatory activities to obtain marketing authorizations for pharmaceutical products /liliManagement and/or support of activities as Responsible for Information and Publicity (RIP) /liliManagement of local (BeNeLux) pharmacovigilance activities including input to safety reports and management of ICSR as local QPPV /liliContribution to reimbursement files by medical writing and/or budget impact analysis and RWE collection. /liliContribution to Medical Affairs projects such as development of patient journeys, slide decks for training, patient, HCP and marketing materials. /liliManagement of stakeholder interactions including advisory boards and scientific presentations. /liliInvolvement 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. /liliManagement of field market access research. /liliMaster/PhD degree in science (Biomedical sciences, Biotechnology, Pharmaceutical sciences, Drug Development, Medical Doctor, Biosciences), or equal through experience gained in Pharmaceutical Industry. /liliLanguages: Dutch/French/English (by preference native French or Dutch). /liliPrevious experience in a pharmaceutical company or an agency providing consulting/clinical services to pharmaceutical industry is required. /liliHaving the technical regulatory knowledge of local/EMA regulatory requirements is required. /liliHaving previous exposure to RIP activities is a clear asset. /liliFirst experience with local / EU GVP requirements is valuable. /liliStrong interest to develop market access and medical affairs skills is required. /liliExcellent stress and time management and ability to handle priorities and deadlines. /liliStrong networker with ability to influence internal and external stakeholders. /liliTeam player
- accountable and entrepreneurial. /liliDynamic and ambitious professional. /liliHands-on strategic innovative thinker. /liliAble to manage multiple tasks in a complex environment. /liliPassionate about creating and communicating the value story of healthcare solutions. /liliDetail oriented. /li /ulh3Competitive Salary (dependent on experience) /h3h3Extensive benefit programme, including meal vouchers, end-of-year 13th month mobility budget /h3h332 days of leave (20 legal days and 12 ADV work time reduction days) /h3h3Exposure to an international work environment with cross-border project responsibilities /h3h3Hybrid environment – only 1 day per week in the office (Ghent Office on a Tuesday) /h3h3Flexible working – to help maintain a better work/life balance. /h3pWe 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 /pulliThis role is open to bfull-time /b applicants only. /liliUnfortunately, we are unable to sponsor candidates for this role. /li /ul