This role involves scientific, regulatory, and procedural input and oversight relating to the safety, efficacy and quality aspects of veterinary medicines, specifically on referral procedures to the Committee for Veterinary Medicinal Products (CVMP) of a European organization. The organization plays a central role in the authorisation and monitoring of human and veterinary medicines in the European Union.
Referral procedures are regulatory mechanisms used to conduct complex reviews—often related to safety—of the benefit-risk balance of veterinary medicines at EU level and to resolve divergences between Member States, with the aim of achieving a harmonised approach across the EU regulatory network.
The close-knit, highly specialised veterinary referrals team leads these procedures, consults the legal department and the European Commission on regulatory matters, and ensures consistency with related areas for human medicines, where applicable. The successful candidate will bring strong analytical acumen and the ability to translate complex scientific evidence into well-reasoned, practical solutions.
You will have opportunities to communicate complex issues to different audiences, build consensus among diverse stakeholders and foster collaborative solutions in an international regulatory environment.
What you do
- Provide scientific coordination and regulatory and procedural support for referrals and related procedures concerning veterinary medicinal products, including support to the organization's scientific committees, while balancing the requirements of multiple stakeholders.
- For allocated referral procedures, act as the primary point of contact for internal and external stakeholders; support CVMP rapporteurs and co-rapporteurs during the assessment; and prepare the required documents, including final CVMP outputs such as assessment reports.
- Work with the Member States’ Veterinary Coordination Group for Mutual Recognition and Decentralised Procedures (CMDv) on referral-related matters, including supporting implementation of CVMP outputs at national level.
- Provide verbal and written updates on referral-related matters to the CVMP and CMDv, and prepare content for the relevant webpages of the organization.
- Interpret the regulatory and scientific requirements set out in legislation and guidelines; identify potential risks associated with referral procedures; exercise sound judgement; and prioritise effectively to deliver compliant CVMP outcomes within legal deadlines.
What they ask
- At least 2 years of relevant professional experience gained in a scientific role involving the regulatory evaluation of medicines, either at an EU competent authority for medicines regulation or in a role requiring interaction with EU regulatory authorities, for example in the pharmaceutical industry or a consultancy.
- Experience in analysing and critically evaluating complex scientific and regulatory evidence relating to the quality, safety and efficacy of medicinal products, adapting to evolving information, and developing well-reasoned, practical solutions.
Profile
- Attention to detail, with the ability to consistently deliver accurate, high-quality work within demanding timelines while ensuring compliance with quality and regulatory standards and maintaining a high level of precision.
- Well-developed scientific written and oral communication skills, with the ability to present complex scientific and regulatory issues convincingly to a range of audiences.
- Sound judgement, with the ability to identify risks, balance competing considerations and make evidence-based recommendations.
- Strong interpersonal and collaborative skills, with the ability to build constructive working relationships across multidisciplinary and multicultural teams.
- Ability to work effectively in a compact specialist team, taking ownership while supporting colleagues to deliver shared objectives.
- Knowledge and understanding of the EU pharmaceutical legislation.
Practical
- Enjoy full rights as a citizen of a European Union Member State or Iceland, Liechtenstein and Norway.
- 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).
- Have fulfilled any obligations imposed by applicable laws concerning military service.
- Possess a university degree of a minimum of three years in Medicine or Life Science (e.g. biology, chemistry, biochemistry, pharmacy, pharmacology or other relevant life science degree) that must have been obtained by the closing date of this vacancy notice.
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