Scientific officer

For the European Medicines Agency we are looking for a Scientific officer!

Role summary:

Product Lead in the Office for Therapies for Immune and Inflammatory diseases, ensuring that high quality, consistent scientific, regulatory and procedural input is provided, throughout the product lifecycle.

• Management of a portfolio of products throughout the product life cycle; from initial marketing authorisation (including pre-submission) and through post-authorisation.
• Regulatory and scientific support to scientific committees, the Agency, the EU network of experts, the European Commission, and interactions with stakeholders.
• Contribute to ensure high-quality of EPAR and product information for assigned product portfolio, from clinical/non-clinical perspective.

Standard role duties & responsibilities:

• Provide scientific coordination and regulatory and/or procedural support in relation to the any of the following areas: Development, evaluation and surveillance of medicinal products for human or veterinary use and of Maximum Residue Limits for substances for veterinary use;
• Referrals and related procedures for medicinal products for human or veterinary use;
• Management of requests for scientific advice, protocol assistance, parallel scientific advice with other decision makers (e.g. FDA or HTA bodies), as well as qualifications;
• Preparing the summary report and supporting the coordination of the initial assessment for orphan medicine designation, paediatric investigation plans or limited markets classifications;
• The delivery of high-quality product information through assessment of invented names, product information and its translations, mock-ups and specimens, and provision of advice and training on product information guideline principles;
• Apply EU pharmaceutical legislation to the operations of the Agency as required;
• Lead to the development of regulatory and/or procedural guidance documents and provide training as required;
• Coordinate and supervise the operation of Scientific Committee meetings, Working Parties, Working Groups, Advisory/Expert Groups, etc and related activities;
• Respond to the requests for information received by the EMA in the scientific field.

Role specific duties & responsibilities

• activities of the organisational entity within which the job holder carries out those tasks;
• the set of annual performance and development objectives, which are established together with the reporting officer;
• the requirement to 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.

A fulltime, temporary job from 16-10-2025 until 31-12-2025;

Salary range:

4,757.33 gross per month (5 years of experience)

5,382.68 gross per month (5 - 17 years of experience)

6,890.74 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.

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.

Education:

• A level of education which corresponds to completed university studies of at least three years attested by a diploma;

Experience:

• Up to 3 years of full time professional relevant experience;
• Experience in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting should have been obtained in:
• In the scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines;
• In working with medicinal products containing medical devices and associated regulatory framework;

Skills & Knowledge:

• Knowledge of the EU pharmaceutical legislation and regulatory framework;
• Experience in the centralised procedure;
• Knowledge of the Agency’s regulatory framework;
• Experience in liaising with regulatory authorities and public health authorities;
• Initiative, diplomacy and good judgment;
• Excellent team working skills;
• Strong ability to follow detailed processes and procedures
• Tact and discretion in the handling of confidential files and information;
• Organisational skills;
• Communication skills;
• Scientific writing skills;
• Proficient in English language;
• Proficient in MS Office suite;
• Knowledge and understanding of the EU pharmaceutical legislation.

Got excited? Apply untill the 14th of June, 2025, by leaving your details on our website via the application button