Regulatory Officer

• Monitor, analyse, advise on regulatory and policy areas related to (off-patent) medicines: telematic tools, digital regulatory infrastructure and systems, electronic Product Information (e-leaflet) and digital health strategy.
• Research and monitor policy developments in support of the broader regulatory and scientific strategy of Medicines for Europe.
• Coordinate the corresponding internal 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 to the European Commission, National Competent Authorities, EMA etc.
• Liaise and collaborate with European industry trade associations etc. on common policy issues.
• Inform and support other Medicines for Europe Sector Groups, Committees and Working Groups on horizontal issues – including providing feedback to the Executive and Board.
• Support the organisation and programme development of diverse events on key advocacy topics.
• Develop the response to external public consultations (e.g. draft guidelines), draft position papers, develop and conduct surveys amongst different working groups and keep members informed.
• Contribute to the development of communication and educational materials.

• Master’s Degree in a Scientific domain OR in Regulatory Affairs
• No experience necessary but experienced candidates also considered
• Fluency in English
• Knowledge of marketing authorisation regulatory processes and the supporting IT tools
• Effective communication (written and spoken) with diverse multicultural stakeholders, ability to simplify complex or technical matters
• Strong project management skills
• Proficiency in Microsoft Office
• Proactive team player who takes ownership and has a “can-do” mentality

Competitive Salary + LV, 8€, Phone Subscription, Hospitalisation and Public Transport reimbursed at 100%

The possibility to represent a dynamic European industry and interact with diverse stakeholders

The opportunity to take ownership and be part of a motivated and multicultural team