Job Description
The Agency is looking to recruit a Scientific Officer (Referral Procedure CVMP), who will provide scientific, regulatory and procedural input and oversight relating to the safety, efficacy and quality aspects of veterinary medicines, specifically on referral procedures to the CVMP.
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.
In this job you will:
•Provide scientific coordination and regulatory and procedural support for referrals and related procedures concerning veterinary medicinal products, including support to the Agency'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 EMA webpages.
•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.
The specific tasks of the job holder are further detailed in the activities of the organisational entity within which the job holder carries out those tasks; the set of annual performance and development objectives established together with the reporting officer; and the requirement to comply with SOPs, WINs, the Confidentiality Undertaking and other documentation relevant to the role and its scope.
•Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
•Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
•Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)
Benefits
•In principle, initial 5 year renewable contract with competitive monthly national tax-free salary and household & children’s allowances (where applicable). Contracts of a shorter duration may be offered.
•Privileges including expatriation (for expatriate staff) and education allowances (where appropriate) and additional home leave.
•Relocation assistance.
•Excellent health insurance scheme and social benefits.
•Retirement Pension Plan.
Monthly net salary of 4.449,31 Euro, including local weighting, plus benefits, based on a full-time contract of 40 hours per week.
The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location in Amsterdam, the Netherlands, is 113.2. Please consult the Eurostat and Commission websites for more information on weightings, and the salary and benefit calculators on the EMA careers website.
The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Candidates who reach the final step will be notified by e-mail whether they have been placed on the reserve list and the relevant Talent Pool. Placement on a reserve list and/or Talent Pool does not guarantee an employment offer.
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 - specific conditions
•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), obtained by the closing date of this vacancy notice.
Citizenship (general condition 1) and the university degree (specific condition) will first be verified based on the application form; you will then be required to provide documentary evidence at the interview stage. Failing to present these documents may result in disqualification from the selection procedure. Only eligible candidates will be assessed by the Selection Committee.
Experience you need to have
•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.
Skills and knowledge you need to have
•Attention to detail, with the ability to consistently deliver accurate, high-quality work within demanding timelines while ensuring compliance with EMA quality and regulatory standards and maintaining a high level of precision.
•Well-developed 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.
Competencies you need to have
•Role competencies (intermediate): prioritising and organising. (Basic): scientific product lifecycle and procedure management.
•Sub-family competencies (basic): regulatory frameworks and strategy; applied knowledge management.
•Grade competencies (intermediate): adaptability and agility; coping with pressures and setbacks; analysing and problem-solving.
•Core competencies (intermediate): ethics and integrity; team collaboration; customer centricity; results orientation; communication; cross-cultural sensitivity. (Basic): continuous learning and self-development.
Nice to have
•Experience in regulatory affairs involving EU-wide or national procedures, or other work related to the regulation of medicines, such as safety or efficacy assessment, preferably concerning veterinary medicines.
•Experience in analysing information and reporting on scientific or regulatory matters.
•Understanding of the regulation of veterinary medicines in the EU.
•A qualification or certification in regulatory affairs.
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.
EMA plays a central role in the authorisation and monitoring of human and veterinary medicines in the European Union (EU). In the veterinary field, this includes referral procedures to the Agency's Committee for Veterinary Medicinal Products (CVMP).
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 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 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.
In this job you will:
•Provide scientific coordination and regulatory and procedural support for referrals and related procedures concerning veterinary medicinal products, including support to the Agency'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 EMA webpages.
•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.
The specific tasks of the job holder are further detailed in the activities of the organisational entity within which the job holder carries out those tasks; the set of annual performance and development objectives established together with the reporting officer; and the requirement to comply with SOPs, WINs, the Confidentiality Undertaking and other documentation relevant to the role and its scope.
•Meaningful work contributing to protecting the health of every individual and animal in Europe within multinational, multidisciplinary team
•Development opportunities (e.g. internal mobility, mentoring, peer coaching, career reflection programme, etc.)
•Work-life balance (flexible working arrangements, teleworking, generous annual leave plus official holidays)
Benefits
•In principle, initial 5 year renewable contract with competitive monthly national tax-free salary and household & children’s allowances (where applicable). Contracts of a shorter duration may be offered.
•Privileges including expatriation (for expatriate staff) and education allowances (where appropriate) and additional home leave.
•Relocation assistance.
•Excellent health insurance scheme and social benefits.
•Retirement Pension Plan.
Monthly net salary of 4.449,31 Euro, including local weighting, plus benefits, based on a full-time contract of 40 hours per week.
The local weighting adjusts salaries to the cost of living in the Netherlands compared to Brussels. The current weighting for the EMA's location in Amsterdam, the Netherlands, is 113.2. Please consult the Eurostat and Commission websites for more information on weightings, and the salary and benefit calculators on the EMA careers website.
The aim of this selection procedure is to create a reserve list of qualified and suitable candidates. Candidates who reach the final step will be notified by e-mail whether they have been placed on the reserve list and the relevant Talent Pool. Placement on a reserve list and/or Talent Pool does not guarantee an employment offer.
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 - specific conditions
•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), obtained by the closing date of this vacancy notice.
Citizenship (general condition 1) and the university degree (specific condition) will first be verified based on the application form; you will then be required to provide documentary evidence at the interview stage. Failing to present these documents may result in disqualification from the selection procedure. Only eligible candidates will be assessed by the Selection Committee.
Experience you need to have
•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.
Skills and knowledge you need to have
•Attention to detail, with the ability to consistently deliver accurate, high-quality work within demanding timelines while ensuring compliance with EMA quality and regulatory standards and maintaining a high level of precision.
•Well-developed 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.
Competencies you need to have
•Role competencies (intermediate): prioritising and organising. (Basic): scientific product lifecycle and procedure management.
•Sub-family competencies (basic): regulatory frameworks and strategy; applied knowledge management.
•Grade competencies (intermediate): adaptability and agility; coping with pressures and setbacks; analysing and problem-solving.
•Core competencies (intermediate): ethics and integrity; team collaboration; customer centricity; results orientation; communication; cross-cultural sensitivity. (Basic): continuous learning and self-development.
Nice to have
•Experience in regulatory affairs involving EU-wide or national procedures, or other work related to the regulation of medicines, such as safety or efficacy assessment, preferably concerning veterinary medicines.
•Experience in analysing information and reporting on scientific or regulatory matters.
•Understanding of the regulation of veterinary medicines in the EU.
•A qualification or certification in regulatory affairs.
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.
EMA plays a central role in the authorisation and monitoring of human and veterinary medicines in the European Union (EU). In the veterinary field, this includes referral procedures to the Agency's Committee for Veterinary Medicinal Products (CVMP).
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 EMA Legal Department and the European Commission on regulatory matters, and ensures consistency with related areas for human medicines, where applicable.
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