About this position:

European Medicines Agency is looking for a Legal Specialist to:

• provide legal advice to the whole of the Agency in order to facilitate the fulfilment of legal, administrative and policy obligations in compliance with EU legislation;
• provide legal advice in relation to the review of new legislation, in particular the new EU Pharma Legislation and upcoming EU Acts and their implementation and
• address judicial and quasi-judicial proceedings.

The Legal Department, is composed by three Offices, namely: the Litigation Office, Pharma Law and Support to Core Business Office and the General Affairs and Anti-Fraud Office.

For this position, the suitable incumbent will be placed, depending on appropriate expertise, either in Litigation Office or in Pharma Law and Support to Core Business Office and will be reporting to the respective Head of Office.

In this job you will:

• Provide legal advice for the assigned area of the Agency, preserving the Agency’s interests and integrity;

• Offer legal advice in relation to the review of new legislation proposed by the Commission and its implementation, in consultation with the relevant organisational entities;

• Provide legal scrutiny of EMA scientific opinions and decisions;

• Provide legal advice in the development of legal, regulatory and procedural guidance through internal and external SOPs, advisory notes, etc., with emphasis on information published/to be published on EMA website;

• Contribute to the creation and maintenance of topic files within the Department, as appropriate.

Link to the Role Description of the Legal Specialist outlining generic duties and responsibilities.

Apply if you meet these eligibility criteria:

To be eligible for consideration for this position, you are required to meet the following general and specific eligibility conditions:

General conditions:

1.  Enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
2.  Have 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 (minimum of three years) in the field of Law that must have been obtained by the closing date of this vacancy notice;

2. At least 3 years’  professional experience after obtaining the relevant degree, that must have been obtained by the closing date of the publication.

For general condition 1 and for specific conditions 1 and 2 you will be required to provide proof 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:

Out of the years of professional experience required for eligibility criteria, specific condition point 2:

• At least 3 years of legal professional experience (obtained after Qualification and Registration in a Bar within the EU/EEA) in a law firm specialised in life sciences sector and dealing with pharma regulatory matters and/or within the Legal Department of a life sciences company and dealing with regulatory matters.

Skills and knowledge:

• Thorough knowledge of the EU Pharma Legislation as well as good understanding of the applicable legislation in the EU regarding Medical Devices, Clinical Trials and IVDs (In Vitro Diagnostics).

Certificates:

• Qualified in Legal Bar of EU/EEA Country-Bar Certificate and a Character Good Standing (or equivalent certification) from the respective Bar will be required.

Competencies you Need to Have:

Sub-family competencies:

Administrative excellence    Intermediate
Governance, legal and control    Intermediate
Applied knowledge     Intermediate

Grade competencies:

Adaptability and agility    Intermediate
Analysing and problem solving    Intermediate
Prioritising and organising    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    Intermediate

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

These are Nice to Have:

Education:

• In law equivalent to Master’s degree;
• Specialisation in the field of EU law or EU pharmaceutical law;
• Scientific degree in life sciences.

Experience:

• In litigation before national or EU courts in relation to EU law and European Ombudsman;
• Experience in issues related to Market Access of Medicinal Products, AI applicable framework.