Scientific Specialist (Pharmaceutical Quality)

The European Medicine Agency (EMA) is looking for a Pharmaceutical Scientific Specialist to support the Pharmaceutical Quality Office in delivering its new responsibilities under the Critical Medicines Act. The Quality Innovation Group has been assigned a legal mandate to promote innovation in manufacturing, with the aim of enabling developers of critical medicines to modernize their processes and strengthen the resilience and robustness of supply chains for 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, 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.

In this role you will:

• Provide scientific specialist support in the development and evaluation of Module 2 and 3 quality aspects of medicinal products for human use across the product life cycle, including pre-authorisation, initial MAA and post-authorisation.
• Manage requests for scientific advice, protocol assistance, and parallel scientific advice on 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.
• Support pharmaceutical quality aspects of innovation and advanced manufacturing technologies for medicinal products of biological origin 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 Groups, and Expert Groups on pharmaceutical quality aspects of human medicinal products of biological origin.
• Respond to requests for information received by the EMA on pharmaceutical quality matters.

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.
2. Have at least 3 years of professional experience after obtaining the relevant degree, acquired by the closing date of the publication.

You will also need to have:

Experience:

At least 3 years of experience in either a competent authority in the field of medicines regulation and assessment, the pharmaceutical industry, or an academic setting, obtained in one of the following areas:

• Scientific or regulatory aspects of the research, development, authorisation or production 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 to experts.
• Knowledge of pharmaceutical development and manufacturing applied to human medicines containing a biological substance.
• Knowledge and understanding of 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

These are considered nice to have:

• 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, including industry and national/international authorities.

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to candidates. The successful candidate will be required to relocate to the Netherlands to take up duties.

What do we offer?

• Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary teams.
• Development opportunities, such as internal mobility, mentoring, peer coaching, and career reflection programmes.
• Work-life balance through flexible working arrangements, teleworking, generous annual leave, and official holidays.
• Initial 5 year contract with competitive monthly tax-free salary and household and children’s allowances, where applicable.
• Privileges for expatriate staff including expatriation and education allowances, where appropriate, and additional home leave.
• Relocation assistance.
• Excellent health insurance scheme and social benefits.
• Retirement pension plan.