For the European Medicines Agency we are looking for a SME Officer in the Small and Medium Sized Enterprise Office (SME)!
What are you going to do?Role summary:
Provide financial and administrative assistance to the Small and Medium Sized Enterprise Office (SME) pursuant to Regulation (EC) No. 2049/2005 and the coordination of related activities in line with the strategic agenda of the Agency. This office is established within the Regulatory Science and Innovation Task Force.
The mission of the Regulatory Science and Innovation Task Force is to enable the continuous future-proofing of the Agency. It seeks to offer an enhanced first point of contact service to developers, in particular small and medium-sized enterprises (SMEs) and academia. It also works towards strengthening the availability of medicines to protect the health of European citizens.
Standard role duties & responsibilities:
- Review small and medium-sized enterprise (SME) status applications according to standard operating procedures;
- Provide regulatory, administrative and procedural assistance to SMEs;
- Plan the organisation of workshops and training events for SMEs;
- Plan the organisation of internal and external meetings with stakeholders;
- Supervise the provision of translations of product information for marketing authorisations applications by SMEs;
- Prepare documents, manuals and other relevant communication tools (e.g. newsletters, targeted mailings, user guide);
- Support the Agency activities related to the ‘Publication and access to clinical-trial data’ policy (Policy 70) and the provision of a redaction tool software licence, the pharmacovigilance fee regulation 658/2014 and stakeholders’ engagement;
- Monitor and report SME activities in relevant systems, databases and governance documents;
- Support the implementation and delivery of the Agency and the European medicines regulatory network strategies relating to Regulatory Science and Innovation;
- Identify and address future challenges from innovative scientific developments by contributing to the operation of the Regulatory Science Observatory across the Agency;
- Forecast and analyse trends in science and technology, upcoming products and their impact on EMA’s work by contributing to a systematic horizon scanning capability.
What do we offer?A fulltime, temporary job from 1-07-2025 until 31-03-2026;
Salary range:
4,812.17 gross per month (5 years of experience)
5,444.73 gross per month (5 - 17 years of experience)
6,970.17 gross per month (17 years of experience or more)
Interesting and challenging work that brings value to European citizens;
A diverse and stimulating working environment.
Where will you work?The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. The agency is located in Amsterdam, Netherlands and employs over 900 people from across the EU. EMA's mission is to protect public health by ensuring that all medicines available in the EU are safe, effective, and of high quality.
What do we ask?Education:
- A level of education which corresponds to completed university studies of at least three years attested by a diploma.
- Field of study - Life Sciences (e.g. biology, biochemistry, chemistry, pharmacy, medicine).
Experience:
- At least 6 months and up to 3 years of full time relevant professional experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare/academic setting obtained on scientific, regulatory or procedural aspects of research, development, authorisation, manufacturing or supervision of human or veterinary medicines;
- In legal and regulatory framework for medicinal products in the EU.
- In verification of enterprises’ compliance with the EU SME definition;
- In preparing and updating of SOPs/WINs, templates and other quality management systems documents and guidance.
Skills & Knowledge:
- Organisational skills;
- Time management skills;
- Communication skills;
- Attention to details;
- Knowledge of the legal and regulatory framework for medicinal products in the EU;
- Knowledge of commonly used IT tools and systems, including teleworking tools and meeting organisers.
Are you interested?Got excited? Apply untill the 9th of May, 2025, by leaving your details on our website via the application button.