EMA sta assumendo un/una
Senior Scientific Specialist (Product Lead)
Amsterdam, Netherlands
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)
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 Specialist 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.
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
| Deadline for applications | 09 November 2026 23:59 CET
| Preliminary Assessments | Last week of November 2026
| Final assessments | January 2027
| Decision expected | February 2027
| Preliminary Assessments | Last week of November 2026
| Final assessments | January 2027
| Decision expected | February 2027