The European Medicines Agency (EMA) is located in Amsterdam, the Netherlands. Serving a population of 500 million citizens, we promote and protect public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU...
The European Medicines Agency (EMA) is located in Amsterdam, the Netherlands. Serving a population of 500 million citizens, we promote and protect public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. Within the Agency, Product Leads work on human medicines, providing scientific, regulatory and procedural input on the safety and efficacy of medicinal products for human use and supporting the work of the EMA's scientific committees. The office supports the development, evaluation and surveillance of human medicines throughout their lifecycle, from pre-submission and initial marketing authorisation to post-authorisation, and provides therapeutic area support to the EU network of experts, the European Commission and other relevant stakeholders. Its activities include the scientific coordination of working parties, the development of scientific guidelines, regulatory science projects and interactions with learned societies and international regulatory authorities. It works as part of the European Medicines Regulatory Network.
Your tasks
The Agency is looking to recruit a number of Senior Scientific Specialists (Product Lead), who will provide scientific, regulatory and procedural input relating to the safety and efficacy aspects of human medicines and lead the product teams for an assigned portfolio of products. The role helps ensure that the scientific opinions of the EMA committees are of high regulatory and scientific standards and are adopted in accordance with the legal timelines. It may include scientific coordination of clinical working parties and contribution to scientific guidelines. In this job you will: _Portfolio management_
- Manage an assigned product portfolio, coordinating scientific, regulatory and procedural activities for timely, high-quality evaluation procedures across the lifecycle, from pre-submission and initial marketing authorisation to post-authorisation, with emphasis on clinical aspects and benefit/risk evaluation.
- Lead and coordinate Product Team activities, facilitating alignment between contributors, supporting prioritisation and enabling effective scientific and regulatory decision-making.
- Identify, monitor, resolve and/or escalate scientific, procedural and operational risks, issues and dependencies affecting assigned products and procedures.
- Build and maintain effective working relationships with rapporteurs, committee members, experts, applicants and other stakeholders to support delivery of regulatory outcomes.
- Provide regulatory, procedural and scientific support on the safety and efficacy of human medicines to the scientific committees, including referrals and related procedures.
- Provide therapeutic area support to other Agency procedures, the EU network of experts, the European Commission and other stakeholders on the development, evaluation and surveillance of human medicines.
- Be responsible for outcome and opinion documents for pre- and post-authorisation procedures, ensuring high-quality EPARs and product information for the assigned portfolio.
_Working parties, guidelines and guidance management_
- Provide scientific coordination to Working Parties, Working Groups, Advisory/Expert Groups and related activities.
- Lead the development of scientific, regulatory and/or procedural guidance documents and provide training as required.
_Other activities_
- Assess and finalise PRIME eligibility reports.
- Lead or contribute to regulatory science projects and topics within the office and across the Agency.
- Present in internal and external fora and prepare or contribute to scientific publications relevant to the therapeutic areas of the office.
- Contribute to activities with learned societies and other external stakeholders, and to interactions with regulatory authorities and partner organisations outside the EU.
The generic duties and responsibilities of the role are further outlined in the full role description of the Senior Scientific Specialist.
Your profile
Eligibility criteria - general conditions
- Full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway.
- Thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2).
- Fulfilled any obligations imposed by applicable laws concerning military service.
Eligibility criteria - qualifications
- A university degree in medicine or life sciences (e.g. biology, chemistry, biochemistry, pharmacy) of minimum four years, obtained by the closing date of this vacancy notice, and at least 9 years of professional experience after obtaining the degree; or
- A university degree in medicine or life sciences of three years, obtained by the closing date of this vacancy notice, and at least 10 years of professional experience after obtaining the degree.
You will be required to provide proof of citizenship and qualifications in the application form and at the interview stage. Failing to present these documents may result in disqualification from the selection procedure. Experience you need to have
- At least 9 years of professional experience in the pharmaceutical industry in non-CMC focused regulatory affairs, including at least 5 years as EU or Global Regulatory Lead (EURL/GRL), or equivalent, leading and defining EU and/or global submission strategies. This experience must be recent, with no gap of more than 2 years between the closing date and your most recent EURL/GRL role.
- Proven experience in leading cross-functional scientific and regulatory project teams, influencing outcomes in complex multi-stakeholder environments without direct authority.
- Proven experience in defining regulatory strategy and providing strategic regulatory guidance throughout product development and lifecycle management.
- Proven experience in translating clinical safety and efficacy aspects of human medicines into regulatory submission strategies and in influencing strategic project decisions through scientific and regulatory expertise.
- Proven experience in leading the preparation for regulatory authority meetings and scientific advice procedures, and in providing strategic regulatory leadership for complex global submissions.
- Excellent stakeholder management abilities and the ability to lead without direct authority.
Skills and knowledge you need to have
- Thorough knowledge of the EU regulatory landscape and in particular the centralised procedure.
- Excellent understanding of clinical development and of the generation, interpretation and integration of clinical evidence to support regulatory decision-making.
Nice to have
- Master's or post-doctoral degree in medicine or life sciences; master's degree in regulatory science and/or regulatory affairs; professional qualifications from an accredited regulatory affairs association (e.g. RAPS or TOPRA).
- Experience in dealing with multiple regulatory agencies, such as EMA, FDA, Health Canada, TGA, PMDA and NMPA.
- Experience with both development-stage and marketed products.
- Awareness of quality/CMC aspects for the development and marketing authorisation maintenance of human medicines.
- Understanding of benefit-risk assessment principles and effective decision-making under uncertainty.
What we offer