Key Skills

Job Description

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related. We have +/- 70 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more! We, Akkodis Life Sciences, are looking for a Scientific Officer – Veterinary Referrals who can strengthen the team at our customer, the European Medicines Agency (EMA) in Amsterdam. Role summary In this role, 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 the Agency's Committee for Veterinary Medicinal Products (CVMP). EMA 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. You will join a close-knit and highly specialised veterinary referrals team that leads these procedures, consults the EMA 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 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. Your responsibilities are The duties of the role are performed under supervision, including guidance and support. You will 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 FDA or HTA bodies; 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 Agency; 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 EMA in the scientific field. Role specific duties & responsibilities Provide scientific coordination and regulatory and procedural support for referrals and related procedures concerning veterinary medicinal products, including support to EMA'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 throughout the assessment process. Prepare required documentation, 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. Support the implementation of CVMP outputs at national level. Provide verbal and written updates on referral-related matters to the CVMP and CMDv. Prepare relevant scientific and regulatory content for EMA 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 prioritise activities to deliver compliant CVMP outcomes within legal deadlines. Communication and professional contacts In this position, you will work closely with colleagues, scientific experts and stakeholders across EMA and the wider European regulatory network. In particular, you will: 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 EMA 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. Experience & Background 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 analysing 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. The following would be considered an advantage: 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 organisation 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. Skills & Knowledge 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 organisational skills; Proficient in the English language; Proficient in the MS Office suite; Knowledge and understanding of EU pharmaceutical legislation and medicines regulation. What do we offer? Employment for 40 hours per week and the opportunity to work at innovative and progressing companies. You will be part of a fast-growing Life Sciences team that is represented in different industries (biotech, pharma, food) and present in Life Sciences clusters in the Netherlands. Temporary contract, depending on the budget the possibility to extend; Attractive salary; The opportunity to work at the European Medicines Agency in Amsterdam; Work-life balance with 24 to 36 holidays; Company fitness, health insurance and good pension scheme; Annual team events; Options to attend training, coaching and a personal development scheme; Career opportunities matching your aspirations and development. Are you interested in this challenge, or do you want to come in touch? Please contact your Talent Acquisition Specialist at Akkodis Life Sciences by sending your CV and motivation letter to [email protected]. Please include the following details in your CV: The period of education(s), jobs and internships: dd-mm-yyyy till dd-mm-yyyy Whether jobs, internships and traineeships were paid or unpaid Whether jobs, internships and traineeships were full-time or part-time (%)

Core Responsibilities

Coordinate and provide scientific, regulatory, and procedural support for veterinary medicine referral procedures, including supporting CVMP rapporteurs, preparing assessment reports, and liaising with EMA, CMDv, and other stakeholders. Interpret scientific evidence and EU regulatory requirements, identify procedural risks, communicate updates, and help ensure compliant outcomes within legal deadlines.

Requirements

A university degree of at least three years in a relevant life science discipline and up to three years of relevant professional experience are required, including experience evaluating medicines and engaging with EU regulatory authorities. Candidates should have strong analytical, communication, organisational, and collaborative skills, knowledge of EU pharmaceutical legislation, and proficiency in English and Microsoft Office.

Benefits

• Attractive Salary
• 24 To 36 Holidays
• Company Fitness
• Health Insurance
• Pension Scheme
• Training
• Coaching
• Personal Development Scheme
• Career Opportunities