SME officer

About this position:

The EMA SME Office is looking for an SME officer to help foster a supportive regulatory environment for small and medium-sized enterprises (SMEs). In this role,  you will help SMEs in navigating the EU regulatory system and accessing key incentives, directly supporting the Agency’s strategic priorities of promoting innovation and strengthening the competitiveness of the European life sciences sector.

The role includes providing financial and administrative support to small and medium-sized enterprises (SMEs) pursuant to Regulation (EC) No 2049/2005 (EMA SME Regulation),  Regulation (EU) 2024/568 (Fees), and related activities under Regulation (EU) 2017/745 (Medical Devices) and Regulation (EU) 2017/746 (In Vitro Diagnostic Devices).

In this role 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. 

Here is the link to the SME officer Role Descriptions, outlining generic duties and responsibilities: SME Officer (CF-01-05-300)

Apply if you meet these eligibility criteria:

General Conditions: 
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.

Specific Conditions:
1. 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.
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General Condition 1 and Specific Conditions 1 will be verified firstly based on the application form and then you will be required to provide documentary evidence at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.
Only candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.

You will also need to have:

Experience

• 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.

Competencies you will need to have:

Role competencies

• Continuous improvement, Basic 
• Regulatory frameworks & strategy, Intermediate

Sub-family competencies 

• Understanding business context, Intermediate 
• Corporate communication, Basic
• Applied knowledge, Intermediate

Grade competencies 

• Adaptability and agility, Intermediate 
• Coping with pressures and setbacks, Intermediate 
• Analysing and problem solving, Intermediate 

Core competencies 

• Ethics and integrity, Intermediate 
• Team collaboration, Intermediate 
• Customer centricity, Intermediate 
• Results orientation, Intermediate 
• Communication, Intermediate 
• Cross-cultural sensitivity, Intermediate 
• Continuous learning and self-development, Basic 

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For more information about definitions of competencies and associated proficiency levels, please refer to the EMA Competency Framework.

These are considered nice to have:

Education

• Master’s degree or course in regulatory affairs.

Experience

• In analysing and reporting on scientific/regulatory matters;
• In preparing, reviewing or assessing a regulatory application dossier;
• In dealing with internal and external stakeholders (industry and national/international authorities);
• In working in an international organisation;
• In preparing and updating of SOPs/WINs, templates and other quality management systems documents and guidance.

Skills & Knowledge

• Understanding of pharmaceutical, (non)clinical, pharmacovigilance regulatory requirements in pre- and post-authorisation;
• Understanding of EMA roles and responsibilities, and activities of the Committees.

Certificates

• Certificates corresponding to the aforementioned requirements.