SNE/Scientific Specialist

About this position:

The European Medicines Agency (EMA) is a decentralised agency of the European Union based in Amsterdam, the Netherlands, at the heart of Europe’s medicines regulatory system. EMA plays a vital role in the protection and promotion of human and animal health, ensuring that safe, effective, and high quality medicines are available to patients across the EU through robust scientific evaluation and oversight.

EMA is offering an opportunity for a Seconded National Expert (SNE) to join H QS QUA (Pharmaceutical Quality Office). A Scientific Specialist is sought to support the office in delivering its new responsibilities under the New pharmaceutical legislation, a key EU initiative aimed at strengthening the competitiveness, innovation and resilience of medicines development and availability in Europe.

In this role, you will provide scientific and regulatory expertise on pharmaceutical quality aspects of human medicines of biological or chemical origin. The ideal candidate brings hands on experience in regulatory assessment of quality/CMC aspects in scientific advice, initial or lifecycle marketing authorisation applications from a national competent authority and is motivated to contribute at the EU regulatory level.
A key objective is support to innovation in early development and pharmaceutical manufacturing in order to develop new product modalities and modernise production processes so that innovative medicines can reach patients across the European Union in a timely manner.

Joining EMA in this role means contributing to forward looking regulatory science, supporting innovation where it matters most, and making a tangible difference to public health at European level.
H-QS-QUA is looking for a scientific specialist, to support the pharmaceutical quality office to manage the new responsibilities for H-QS-QUA from the new pharmaceutical legislation. The candidate should ideally have assessment experience managing the technical/scientific side of quality dossiers in a specialist role, to provide scientific and regulatory input and oversight to quality aspects of human medicines of biological or chemical origin. 

In this job you will:

• Provide support in relation to the following areas:
  • Development and evaluation of Module 2 and 3 quality aspects of medicinal products for human use across the product life cycle (preauthorisation, initial MAA and post-authorisation);
  • Management of requests for scientific advice, protocol assistance, parallel scientific advice of quality aspects of human medicines of biological or chemical active substances;
  • Pharmaceutical quality aspects of innovation and advanced manufacturing technologies for medicinal products for human use in the context of the Quality innovation group. 
• Coordinate and supervise the operation of Scientific Committee meetings, Working Parties, Working Groups, Advisory/Expert Groups, etc. on pharmaceutical quality aspects of human medicinal products;
• Respond to the requests for information received by the EMA on pharmaceutical quality matters.

Apply if you meet these eligibility criteria:

• Enjoy full rights as a citizen of an EU Member State, Iceland, Lichtenstein, Norway, Republic of Moldova or Ukraine;
• Have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union;
• Currently  employed in the public sector (such as a university, research institute, public hospital or regulatory body) in a European Union (EU) Member State, the European Free Trade Area (EFTA), candidate countries and public intergovernmental organisations (IGOs).

You will also Need to Have:

Education

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

Field of study

• scientific (pharmacy, chemistry, biology or an equivalent) or technical (e.g. applied science)

Experience

• At least 3 years experience obtained in either a competent authority in the field of medicines regulation and assessment, the pharmaceutical industry or in an academic setting should have been obtained in either in:
  •    scientific or regulatory aspects of the research, development, authorisation or productions of human medicines
  •    working on pharmaceutical quality aspects of medicinal products containing medical devices and their associated regulatory frameworks;

Skills & Knowledge

• Critical review an preparation of assessment of quality/CMC aspects of human medicines;
• Presenting scientific, or regulatory matters at a high level (including experts);
• Knowledge of pharmaceutical development and manufacturing applied to human medicines containing biological or chemical  substances,
• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU;

Certificates 
n/a

Nice to have

Experience

• Experience with platform technologies and ASMF/master file certification scheme;
• Experience in the preparation and/or review of any part of an application dossier;
• Experience in working with stakeholders (industry and national/international authorities).

Skills & Knowledge

• Knowledge of pharmaceutical  quality aspects of innovative chemicals or biologicals ( e.g. synthetic peptides, oligonucleotides, mRNA, and gene therapy);