Scientific Specialist (Pharmaceutical Quality)

About this position:

The European Medicine Agency (EMA) is looking for a Pharmaceutical Scientific Specialist to support the Pharmaceutical Quality Office (H-Qs-QUA) in delivering its new responsibilities under the Critical Medicines Act. Under this Act, the Quality Innovation Group (QIG) has been assigned a legal mandate to promote innovation in manufacturing. The aim is to enable developers of critical medicines to modernize their processes, ultimately strengthening the resilience and robustness of supply chains for the benefit of patients across the EU.
 
The ideal candidate will bring experience in quality assessment or hands‑on expertise in managing the technical and scientific aspects of quality dossiers in a specialist role. The selected candidate will provide scientific and regulatory input, as well as oversight of quality aspects for human medicines of biological origin, with a particular focus on recombinant proteins, vaccines, or ATMPs.
 
If you have a strong understanding of biological manufacturing and regulatory frameworks, if you are motivated to work at the intersection of science, regulation, and public health and have a passion for contributing to EU‑wide initiatives with tangible, positive impact on patient outcomes, this position is for you!

Here is the link to the Role Description of Scientific Specialist outlining the generic duties and responsibilities:

https://www.ema.europa.eu/en/documents/recruitment/role-description-scientific-specialist_en.pdf

In this role you will:

• Provide scientific specialist 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 with a focus on biological active substances;
  • Lead the development of regulatory and/or procedural guidance documents in the area of quality of medicines with a focus on biologicals and provide training as required;
  • Pharmaceutical quality aspects of innovation and advanced manufacturing technologies for medicinal products of biological origine 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 of biological origine;
• Respond to the requests for information received by the EMA on pharmaceutical quality matters. 

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 Pharmacy, Biology, Chemistry, Biochemistry, Engineering or other relevant life-science disciplines that must have been obtained by the closing date of this vacancy notice,
and 

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

General Condition 1 and Specific Conditions 1 and 2  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 3 years experience 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 one of the following areas:

•    scientific or regulatory aspects of the research, development, authorisation or productions of human medicines
•    pharmaceutical quality aspects of medicinal products containing medical devices and their associated regulatory frameworks;

Skills & Knowledge: 

• Critical review and drafting of scientific and regulatory documents for expert and lay audiences;
• Presenting scientific, or regulatory matters at a high level (including experts);
• Knowledge of pharmaceutical development and manufacturing applied to human medicines containing a biological substance;
• Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU.

Competencies you will need to have:

Role competencies      

• Developing and applying innovative practices – Intermediate
• Scientific evidence management, Intermediate

Sub-family competencies     

• Regulatory frameworks & strategy - 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

The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.

These are considered Nice to have:

Experience

• Knowledge of pharmaceutical  quality aspects of complex biologicals (for example microbiota, mRNA, and gene therapy);
• Experience with platform technologies and ASMF/master file certification scheme;
• Exposure to modelling, digitalisation in manufacturing, and personalised medicine; 
• Experience in the preparation and/or review of any part of an application dossier;
• Experience in working with stakeholders (industry and national/international authorities).