Scientific (SME) Officer

Job

In this role, you will help SMEs (small and medium-sized enterprises) in navigating the EU regulatory system and accessing key incentives, directly supporting the European Medicines Agency’s strategic priorities of promoting innovation and strengthening the competitiveness of the European life sciences sector.

In particular, you will:

• Review small and medium-sized enterprise (SME) status applications according to standard operating procedures;
• Provide regulatory, administrative and procedural assistance and support 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);
• 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, innovation and competitiveness;
• Collaborate with Commission Directorates/European Agencies and European Institutions in related areas of activity;
• Represent the Agency in external meetings and public conferences;
• Collaborate with international institutions in related activities.

Read full description and requirements here: SME officer Job Details | EMA

Profile

1. Enjoy full rights as a citizen of a European Union Member State or Iceland, Lichtenstein and Norway.
2. A thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
3. Have fulfilled any obligations imposed by applicable laws concerning military service.
4. Possess a university degree of a minimum of three years in Life Sciences (e.g. medicine, biology, chemistry, biochemistry, pharmacy) that must have been obtained by the closing date of this vacancy notice.
5. At least 1 year experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare/academic setting obtained on the scientific, regulatory or procedural aspects of research, development, authorisation, manufacturing or supervision of human and/or veterinary medicines;

Skills & Knowledge

• Knowledge and understanding of the legal and regulatory framework for medicinal products in the EU;
• Knowledge and understanding of EU SME definition;
• Organisational skills;
• Attention to details.

Read full description and requirements here: SME officer Job Details | EMA

Benefits

• Initial 5 year contract.
• competitive monthly tax-free salary (4,449.31 Euro based on a fulltime contract (40hrs/week), plus benefits like expatriation or household & children’s allowances (where applicable)
• Privileges for expatriate staff including expatriation and education allowances (where appropriate) and additional home leave
• Relocation assistance
• Excellent health insurance scheme and social benefits
• Retirement Pension Plan

Company profile

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU). It is responsible for the scientific evaluation, supervision and safety monitoring of medicines.

At EMA we foster scientific excellence in the evaluation and supervision of medicines.

EMA protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA serves a community of around 450 million people living in the EU, and has been operating since 1995.