You will provide scientific, regulatory and procedural input and oversight relating to the safety, efficacy and quality of veterinary medicines, with a particular focus on referral procedures to a specialized committee. A European governmental organization plays a central role in the authorization 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 harmonized approach across the EU regulatory network.
You will join a close-knit and highly specialized team that leads these procedures, consults a legal department and a European body on regulatory matters and ensures consistency with related areas for human medicines, where applicable. The successful candidate will bring strong analytical skills and the ability to translate complex scientific evidence into well-reasoned and practical solutions.
You will communicate complex issues to different audiences, build consensus among diverse stakeholders and contribute to collaborative solutions within an international regulatory environment.
What you do
- Provide scientific coordination and regulatory and/or procedural support in relation to areas including:
- Development, evaluation and surveillance of medicinal products for human or veterinary use and Maximum Residue Limits for substances for veterinary use;
- Referrals and related procedures for medicinal products for human or veterinary use;
- Management of requests for scientific advice, protocol assistance and parallel scientific advice with other decision makers, such as national or international health authorities;
- Preparation of summary reports and support for the coordination of initial assessments;
- Delivery of high-quality product information;
- Application of EU pharmaceutical legislation to the operations of the organization;
- Development of regulatory and/or procedural guidance documents and provision of training where required;
- Coordination and support of Scientific Committee meetings, Working Parties, Working Groups and Advisory/Expert Groups;
- Responding to requests for information received by the organization in the scientific field.
- 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 the committee's rapporteurs and co-rapporteurs throughout the assessment process.
- Prepare required documentation, including final committee outputs such as assessment reports.
- Work with a Member States' coordination group for Mutual Recognition and Decentralised Procedures on referral-related matters.
- Support the implementation of the committee's outputs at national level.
- Provide verbal and written updates on referral-related matters to the committee and the coordination group.
- Prepare relevant scientific and regulatory content for the organization's webpages.
- Interpret regulatory and scientific requirements set out in applicable legislation and guidelines.
- Identify potential risks associated with referral procedures, exercise sound judgement and effectively prioritize activities to deliver compliant committee outcomes within legal deadlines.
Communication and professional contacts.
- Liaise with internal and external stakeholders, interested parties and subject-matter experts;
- Coordinate, support and contribute to effective communication and stakeholder relationships;
- Communicate daily with colleagues across the organization and extended product teams regarding the management of procedures;
- Prepare and contribute to communication documents for allocated procedures;
- Contribute to the preparation of Scientific Committee meetings, Working Parties, Working Groups and Advisory/Expert Groups, including providing scientific support where applicable;
- Explain and interpret complex scientific, regulatory and procedural information to different audiences;
- Build constructive relationships and support collaboration between different stakeholders.
What they ask
- A completed university degree of at least three years in a relevant Life Science discipline, such as Biology, Chemistry, Biochemistry or Pharmacy;
- Up to 3 years of full-time relevant professional experience;
- Relevant professional experience in a scientific role involving the regulatory evaluation of medicines;
- Experience gained either at an EU competent authority for medicines regulation or in a position requiring interaction with EU regulatory authorities, for example within the pharmaceutical industry or a consultancy;
- Experience analyzing and critically evaluating complex scientific and regulatory evidence relating to the quality, safety and efficacy of medicinal products;
- Ability to adapt to evolving scientific and regulatory information and translate this into well-reasoned, practical solutions;
- Knowledge and understanding of EU pharmaceutical legislation.
- Strong analytical skills and attention to detail;
- Ability to consistently deliver accurate and high-quality work within demanding timelines;
- Strong written and oral communication skills;
- Ability to communicate complex scientific and regulatory issues convincingly to different audiences;
- Sound judgement and the ability to identify risks and balance competing considerations;
- Ability to develop evidence-based recommendations;
- Strong interpersonal and collaborative skills;
- Ability to build constructive working relationships across multidisciplinary and multicultural teams;
- Ability to work effectively within a compact specialist team, taking ownership while supporting colleagues in achieving shared objectives;
- Strong organizational skills;
- Proficient in the English language;
- Proficient in the MS Office suite;
- Knowledge and understanding of EU pharmaceutical legislation and medicines regulation.
Desirable.
- A Master's degree in Medicine, Life Sciences or another relevant scientific discipline;
- Experience in Regulatory Affairs, particularly EU-wide or national regulatory procedures or other work involving the regulation of medicines;
- Experience in scientific/regulatory information analysis and reporting;
- Clinical experience within a therapeutic field;
- Experience working within a multinational organization and managing multiple international stakeholders;
- Non-clinical experience within a Good Laboratory Practice (GLP) laboratory;
- Additional knowledge or experience relating to medicines regulation;
- Certification or training relating to evaluation of medicines and/or Regulatory Affairs.
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