Regulatory Policy Officer (Digitalisation & New Technologies)

About the Organisation

Medicines for Europe is the leading trade association representing the generic medicines industry as well as biosimilar and value-added medicines at the European level. Guided by our five core values — Patients, Quality, Value, Sustainability, and Partnership — we work at the heart of EU pharmaceutical policy to ensure that safe, effective, and affordable medicines remain accessible to patients all across Europe.

We are looking for a dynamic and proactive Regulatory Policy Officer focused on digitalisation & new technologies to join our team in Brussels. In this role, you will be at the forefront of shaping digital solutions and data driven regulatory processed critical for pharmaceutical companies, , engaging with the regulatory authorities, EU institutions and relevant stakeholders, that make a real difference in European regulatory environment and European healthcare.

If you are passionate about emerging technologies, driven by impact on pharmaceutical sector, one of the most critical sectors in European policy-making, we want to hear from you.

Founded in 1993, Medicines for Europe is the voice of the generic, biosimilar, and value-added medicines industries, representing companies that supply the largest share of prescription medicines across Europe, covering over 80% of therapy areas. As the leading partner for political change at the EU level, we work to improve healthcare access, enhance the health and wellbeing of all Europeans, and safeguard the long-term sustainability of Europe’s healthcare systems for generations to come.

Joining Medicines for Europe means being part of an organisation where your work has real, measurable impact: on policy, on healthcare systems, and on patients’ lives across the continent.

About the Role

The Regulatory Policy Officer will manage essential European regulatory and policy initiatives and projects with a key emphasis on new technologies and telematic tools, digital regulatory infrastructure and systems, electronic Product Information (e-leaflet), use of AI, and digital health strategies.

They will interact with membership and external partners including health authorities and EU institutions and support the Medicines for Europe Team for projects and events, including the implementation of the revised Pharmaceutical Legislation.

Reporting to the Executive Director, Regulatory & Scientific Affairs, the Regulatory Policy Officer will:

• Monitor, analyse, advise on a number of regulatory and policy areas related to (off-patent) medicines: electronic Product Information (e-leaflet), telematic tools, digital regulatory infrastructure and systems, digital health strategy and AI.
• Engage in the implementation process of the revised Pharmaceutical legislation.
• Research and monitor policy developments and key topics in support of the broader regulatory & science strategy of Medicines for Europe.
• Coordinate the corresponding internal committee, working groups and task forces, including drafting of agendas, minutes, reports and briefing notes, as well as data collection.
• Represent Medicines for Europe and advocate on its behalf on these issues towards the relevant external decision makers and other stakeholders such as the European Commission, National Competent Authorities, EMA and others.
• Liaise & collaborate with other European industry trade associations and other stakeholders on common policy issues on behalf of Medicines for Europe.
• Inform & support other Medicines for Europe Sector Groups, Committees and Working Groups on horizontal issues.
• Provide feedback to the Executive and Board on the issues indicated above, as appropriate.
• Support the organisation and programme development of conferences (events, sessions, workshops) on key advocacy topics.
• Develop the response to external public consultations (e.g. draft guidelines), produce position papers and communications, develop and conduct surveys amongst different working groups and inform association members of developments in the areas indicated above.
• Contribute to the development of communication and educational materials as needed.

About your Profile

• A Master’s degree in a relevant field, either in health policy, law, OR in medical/healthcare science, pharmaceutics and similar.
• At least 2 years’ experience in European health/pharmaceutical policy, pharmaceutical industry, advocacy groups, regulatory authority or in any other organisation dealing with the above areas
• Knowledge of marketing authorisation regulatory processes and the IT tools supporting them will be an advantage
• Experience in advocating towards decision makers would be an asset.
• Written and spoken proficiency in English with a knowledge of additional EU languages is an asset.
• Excellent project management skills including ability to handle multiple parallel projects and flexibility to adapt and reprioritise time sensitive issues.
• Dynamic, entrepreneurial (proactive & autonomous) and high self-motivated personality with a “can-do” mentality.
• Strong communication, writing and presentation skills.
• Comfortable in a multicultural environment
• Strategic thinking and creativity to convey complex ideas clearly.
• A valid EU work permit.

About the Offer

• The opportunity to impact the lives of millions of patients and consumers, as well as the functioning of an entire sector of the European economy with your work and problem-solving skills.
• Full-time position: a one-year contract with the potential to turn it into an indeterminate one.
• A salary package including meal vouchers (8€ per working day), a net remote work allowance, hospitalisation insurance (+ ambulatory) and pension fund.
• Hybrid work arrangement.
• The possibility to represent a dynamic European industry and interact with diverse stakeholders and an extensive level of external exposure.
• Regular European travel.
• The opportunity to take ownership and have impact as well as being part of a motivated and multicultural team.

About your Application

Interested candidates are asked to submit their applications consisting of Cover Letter and recent CV to the Recruitment Team at sergey.golyshin@mavence.com AND info@mavence.com .

The deadline to apply is the 8^th June 2026 at 23:59 with early applications to be encouraged.