Senior Scientific Specialist (Product Lead)

Type of position:
Temporary agent

Job Type:
09 November 2026 at 23.59 CET

Job grade: AD 8

Internal/Inter-agancy job grade: AD 8 and above

Type of position: Temporary agent

Selection procedure reference: EMA/TA/11616

Job title: Senior Scientific Specialist (Product Lead)

Talent Pool: AD08 Science & Regulation

Deadline for applications: 09 November 2026 at 23.59 CET

Monthly net salary: 9,577.39 Euro(including local weighting) [1]plus benefits(see calculators on the right) (based on a fulltime contract (40hrs/week))

Location: Amsterdam; The Netherlands (relocation to take up duties is mandatory)

XX

About this position:

The Agency is looking to recruit a number of Product Leads. The Product Lead is responsible for providing scientific, regulatory and procedural input relating to the safety and efficacy aspects of human medicines. They are responsible for leading the product teams for an assigned portfolio of products. This role helps ensure the scientific opinions of the committees of the EMA are of high regulatory and scientific standards and are adopted in accordance with the legal timelines. The role may include scientific coordination of clinical working parties and contribution to scientific guidelines.

In this job you will:

Provide scientific regulatory and procedural leadership in the following areas:

1) Portfolio management

• Management of an assigned product portfolio, coordinating scientific, regulatory, and procedural activities and facilitating timely and high-quality delivery of evaluation procedures throughout the product lifecycle, from initial marketing authorisation (including pre-submission) to post-authorisation, with particular emphasis on clinical aspects and benefit/risk evaluation.
• Product team leadership: lead and coordinate Product Team activities, facilitating alignment between contributors, supporting prioritisation of activities, and enabling effective scientific and regulatory decision-making;Prioritisation & issue management: identify, monitor, resolve and/or escalate scientific, procedural, and operational risks, issues and dependencies affecting assigned products and procedures;
• Stakeholder management: build and maintain effective working relationships with rapporteurs, committee members, experts, applicants, and other stakeholders to support delivery of regulatory outcomes;
• Regulatory/procedural/scientific support with respect to the safety and efficacy of human medicines to scientific committees;
• Provide scientific support in the context of safety and efficacy aspects, as well as therapeutic area context, to referrals and related procedures for medicinal products for human use;
• Provide therapeutic area support to other procedures and activities in the Agency, the EU network of experts, the European Commission, and other relevant stakeholders on the development, evaluation and surveillance of medicinal products for human use;
• Responsible for the outcome and opinion documents for pre-and post authorisation procedures, ensuring high-quality of EPAR and product information for assigned product portfolio;

2) Working parties, guidelines and guidance management

• Scientific coordination to the Working Parties, Working Groups, Advisory/Expert Groups and related activities;
• Leading the development of scientific, regulatory and/or procedural guidance documents and providing training as required;

In this job you will (continued)

3)Be responsible for other activities including:

• Assessment and finalisation of PRIME eligibility reports
• Presentation on topics in internal and external fora;
• Leading or contributing to regulatory science projects and topics within the office and cross Agency.
• Contribution to activities with learned societies and other external stakeholders relevant to the therapeutic areas of the office;
• Preparation or contribution to scientific publications and/or presentations relevant to the therapeutic areas of the office;
• Contribute to interactions relevant to own specific therapeutic area with other regulatory agencies outside the EU;
• International engagement: contribute to interactions and collaborative activities with international regulatory authorities and partner organisations relevant to the therapeutic area.

Link to the full role description of the Senior Scientific Specialis t outlining generic duties and responsibilities.

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 of minimum of four years in medicine or life sciences (e.g. biology, chemistry, biochemistry, pharmacy, etc.) that must have been obtained by the closing date of this vacancy notice, and at least 9 years professional experience after obtaining the relevant degree, that must have been obtained by the closing date.

Or

2. possess a university degree of three years medicine or life sciences (e.g. biology, chemistry, biochemistry, pharmacy, etc.) that must have been obtained by the closing date of this vacancy notice, and at least 10 years professional experience after obtaining the relevant degree, that must have been obtained by the closing date.

For general condition 1 and for specific conditions 1 and 2 you will be required to provide proof in the application form and 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 need:

Experience

• At least 9 years of professional experience in the pharmaceutical industry acquired through working in non-CMC focused regulatory affairs, with at least 5 years of experience as EU Regulatory Lead or Global Regulatory Lead (EURL/GRL), or equivalent, leading and defining submission strategies in the EU and/or globally. This experience must be recent, with no gap of more than 2 years between the closing date for applications and your most recent experience working as EURL/GRL.

You will have to demonstrate proven experience in:

• Leading on cross-functional scientific and regulatory project teams influencing outcomes in complex multi-stakeholder environments without direct authority;
• Defining regulatory strategy and providing strategic regulatory guidance throughout product development and lifecycle management;
• Translating clinical safety and efficacy aspects of human medicines into regulatory submission strategies;
• Influencing strategic project decisions through scientific and regulatory expertise;
• Leading the preparation for regulatory authority meetings and scientific advice procedures;
• Excellent stakeholder management abilities;
• Ability to lead without direct authority;
• Providing strategic regulatory leadership for complex submissions globally.

Skills & Knowledge

• Thorough knowledge of the EU regulatory landscape and in particular the centralised procedure;
• Excellent understanding of clinical development and the generation, interpretation and integration of clinical evidence to support regulatory decision-making.

Competencies you need to have:

Role competencies

Influencing and persuading  Advanced

Prioritising and organising  Advanced

Scientific evidence management Intermediate

Sub-family competencies

Regulatory frameworks & strategy Advanced

Applied knowledge Advanced

Grade competencies

Adaptability and agility Intermediate

Coping with pressures and setbacks Advanced

Analysing and problem solving Advanced

Core competencies

Ethics and integrity Intermediate

Team collaboration Advanced

Customer centricity Advanced

Results orientation Advanced

Communication Advanced

Cross-cultural sensitivity Advanced

Continuous learning and self-development Intermediate

For more information about definitions of competencies and associated proficiency levels, please refer to the EMA Competency Framework.

These are considered as Nice to Have:

Education

• Master’s or Post Doctoral Degree in a relevant field of study (medicine or life sciences);
• Master’s degree in regulatory science and/or regulatory affairs;
• Professional qualifications from an accredited Regulatory Affairs Professionals association, e.g. RAPS or TOPRA.

Experience

• Experience in dealing with multiple regulatory agencies, such as EMA, FDA, Health Canada, TGA, PMDA, NMPA.
• Experience in both development-stage and marketed products.
• Awareness of quality / CMC aspects for the development and marketing authorization maintenance of human medicines.

Skills & Knowledge

• Understanding of benefit-risk assessment principles;
• Effective decision-making under uncertainty.

Selection procedure timelines

In the interest of fairness and equal treatment of all candidates, requests for re-scheduling of tests/interviews may only be considered in compelling and exceptional circumstances. Such requests must be supported by appropiate documentary evidence.

Selection process

Only eligible candidates (see eligibility criteria) will be assessed by the selection committee.

Suitability and qualifications of eligible candidates will be assessed against the assessment criteria and competences in different steps of the selection procedure.

Note:  Candidates who fail any assessment linked to any Need to Have requirement, Sub-family, grade specific competencies, and Core Competencies at any stage of the process are disqualified, despite getting points on other criteria.

Before the start of the selection procedure, it is decided which criteria and competences will be assessed at each stage of the process. Certain criteria / competences will be assessed / scored only for shortlisted candidates during interviews (and/or tests). Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3. selection procedure) for an overview of the criteria and competences assessed at each stage of the process.

Shortlisting

In order to allow the selection committee to carry out an objective assessment of all candidates in a structured way, as part of their application, all candidates must answer the pre-defined set of questions based on Need to have criteria and sub-family and role competences.

The Selection Committee will therefore assess eligible candidates using the information provided in the responses to those questions and in their application. When answering a question, you should include all relevant information, even if it is already mentioned in other sections of your application form.

To carry out this assessment, each of your responses will be awarded points (0 to 10). The points are added up to identify those candidates whose profiles best match the duties to be performed as advertised in the vacancy notice.

Only the candidates with the highest total marks at the shortlisting stage will progress to the next stage. The Selection Committee will decide to limit the number of candidates invited to the next stages. Please consult the Careers at EMA - Guidance on selection and recruitment (table on section 1.3.6 Preliminary and final assessments) for an overview of the thresholds.

Assessments

Next steps of selection may include a preliminary assessment. Most assessments will be conducted remotely (i.e. Webex/Teams, remote test, etc.). All assessments are based on the assessment criteria listed in this vacancy notice.

Shortlisted candidates will participate in personality assessments (e.g. SHL occupational personality questionnaire OPQ32) to assess their Core Competencies (pass score is 26 out of 100 points and above). In addition, selected Core Competencies may be assessed throughout the process.

Additional assessments, such as cognitive (e.g. deductive reasoning) assessments might also be foreseen as part of the selection process. Furthermore, motivation and overall fit for the job and knowledge of EU relevant to role may be assessed.

Please consult the Careers at EMA - Guidance on selection and recruitment (section 1.3.3 selection procedure) for an overview of the criteria and competences assessed at each stage of the process and the type of assessment tolls used.

Reserve list and/or job offers

The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Each candidate having reached the final step of the selection procedure will be notified via e-mail whether she/he has been placed on the reserve list, and relevant Talent Pool. Candidates should note that the placement on a reserve list and/or Talent Pool does not guarantee an employment offer.

We strongly encourage that candidates do not apply for the vacancies that are at the same grade and the same subfamily as the Talent Pool they have been placed on, as this will not improve their chances of being considered for a vacant post within the Agency.

When a vacancy becomes available, candidates on the reserve list may be contacted for an additional interview.

More information about selection and recruitment (including administrative complaint procedure) at the EMA is available at our careers website.

Conditions of employment

In principle, the Agency offers a five-year renewable contract. Contracts of a shorter duration may be offered to the candidates.

The successful candidate will be required to relocate to the Netherlands to pick up duties.

[1] The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location in Amsterdam, the Netherlands, is 113.2. Please consult the Eurostat and Commission websites for more information on weightings.

\_\_\____________________________________________________________________________________________________

Domenico Scarlattilaan 6 - 1083 HS Amsterdam - The Netherlands

Telephone +31 (0)88 781 6000 - Email recruitment@ema.europa.eu

© European Medicines Agency, 2025. Reproduction is authorised provided the source is acknowledged.

Join us to work for every patient in Europe!