We are seeking a highly organized and detail-oriented individual to join our team as a Regulatory Procedures Assistant at the European Medical Agency. In this role, you will be responsible for providing administrative support and managing regulatory procedures related to the marketing authorization of centrally authorized medicinal products in the EU. Your primary focus will be on processing and issuing Certificates of medicinal products. You will interact with internal and external stakeholders, validate submitted information, maintain databases, and ensure compliance with standard operating procedures (SOPs).
Role-Specific Duties & Responsibilities:
- Carry out tasks assigned by the organizational entity within which you work.
- Meet annual performance and development objectives set by your reporting officer.
- Comply with SOPs, work instructions, confidentiality undertakings, and other relevant documentation.
Communication and Professional Contacts:
- Receive and convey routine information orally and/or in writing.
- Follow SOPs, established rules, policies, and processes.
- Respond to simple inquiries and draft basic material, letters, minutes, reports, or presentations.
- Maintain professional contacts related to your job responsibilities.
- Cooperate with colleagues across departments and divisions.
Waar ga je werken?
The European Medicines Agency (EMA) is a decentralised agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. The agency is located in Amsterdam, Netherlands and employs over 900 people from across the EU. EMA's mission is to protect public health by ensuring that all medicines available in the EU are safe, effective, and of high quality.
Wat vragen wij?
- A level of post-secondary education attested by a diploma;
- a level of secondary education attested by a diploma giving access to post-secondary education, and appropriate professional experience of at least three years.
- Up to 6 years of full time relevant professional ;
- Administrative experience in an office environment;
- Experience in working with IT tools (i.e. Microsoft Office, data bases, document management systems);
- In working in a regulatory environment characterised by processes and procedures, SOPs, WINs or other guidance documents;
- In database management and analysis and reporting;
- In stakeholder management;
- In working in public or regulatory sector.
Wat we bieden:
- A fulltime, temporary job from 01/09/2023 - 31/12/2023;
- Salary between 3.325,77 and 4.257,46 euro gross per month, depending on your qualifications;
- Interesting and challenging work that brings value to European citizens;
- A diverse and stimulating working environment.