Regulatory Officer

Company details

Medicines for Europe represents pharmaceutical companies supplying off-patent prescription medicines and aims to increase Europeans’ health through better access to quality medicines. You will work within the Regulatory and Scientific Affairs Team and be responsible for key European regulatory and policy initiatives.

Function

  • 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.

Profile

  • 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

Offer

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

Placed on:Thu 14 October 2021
Location: Brussels
Profile Group

Bld Louis Schmidt 54
1040 Bruxelles
Belgium

Tel:027320175

Interested?

For more information:
Call EMMA WAITES
at the number: 02 738 02 63 GSM 0475 614967
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