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4 maanden geleden
- Provision of legal advice to the whole of the Agency, the EMA Committees, their Working Parties, on a variety of matters related to EU pharmaceutical law, including provision of regulatory and procedural advice in relation to pharmaceutical products for human and veterinary use;
- Provision of legal advice in relation to the review of new pharmaceutical legislation and its implementation;
- Provide legal advice for the assigned area of the Agency, preserving the Agency’s interests and integrity, and the activities of belonging to this position;
- 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.
- Comply with SOPs, WINs, confidentiality undertaking and other documentation relevant to the role and its scope. These will be agreed upon with the reporting officer upon assuming duties;
- Co-operate with colleagues across departments and divisions in the Agency;
- Liaise with legal colleagues of other Union institutions, bodies, offices and agencies, including through the Inter-Agency Legal Network (IALN), and of other national competent authorities, including through EMACOLEX;
- Participate in meetings of these authorities on a rotational basis / support colleagues attending such meetings.
- A level of education which corresponds to completed university studies of at least three years attested by a diploma;
- Proven professional experience of at least 3 years, after the univeristy degree was awarded;
- Specialisation in the field of EU pharmaceutical law is required;
- Knowledge of and professional experience in the application of EU pharmaceutical law (for example Directive 2001/83, Regulation 726/2004, etc.);
- Experience in organising large and complex meetings/events with multiple stakeholders;
- Experience working in a regulatory environment characterised by processes and procedures, SOPs, WINs or other guidance documents is essential;
- Previous experience in the Pharmaceutical Industry or a Health authority or working on a regulated environment would be prefered;
- Knowledge and understating of commonly used IT tools and systems, such as SIAMED, EPPIT, EVVET, and meeting platforms;
- Proof-reading skills would be prefered;
- Knowledge of the EU regulatory framework and (business) process management is prefered;
- Previous experience in litigation before national or EU courts in relation to EU pharmaceutical law;
- Working with and/or within EU institutions or agencies is prefered;
- Administrative excellence;
- Team collaboration;
- Corporate communication;
- Adaptability and agility;
- Governance, legal and control;
- Applied knowledge;
- Analysing and problem solving;
- Cross-cultural sensitivity;
- Continuous learning and self-development.
The EMA promotes and protectspublic 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 population of approximately 500 million citizens living in the EU.Pharma Law and Support to Core Business Office
