Senior Scientific Specialist; Product Lead

Position: Senior Scientific Specialist (Product Lead)
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.

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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.

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…