Would you like the opportunity to work in a dynamic, young environment? Are you interested in your personal growth, as well as your career’s?
is an IT services, consulting, and business solutions provider that has been partnering with the world’s largest businesses in their transformation journeys.
In our you will work within the Client organization, in the Regulatory Affairs Operations Regional department (EMEA Region).
- Support the regulatory submission creation and the registration tracking of the company, the regulatory submission targets from a regulatory operational perspective for the whole region.
- Review and manage the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs of regional regulatory authority.
- Help with project management tasks, including managing dynamic timelines, interacting and negotiating and collaborating with global stakeholders
Your main functions would be:
- Manage Operations aspects of submission planning for assigned products;
- submission planning
- document retrieval
- submission creation and delivery to Health Authorities
- Bachelor’s degree in a Life Science related discipline.
- High level expertise and knowledge of the regulatory landscape, its registration procedures and a thorough understanding of the technical requirements for dossiers (e.g. eCTD and other submission formats).
- Affinity to work with complex IT systems
- English language knowledge, intermediate or above
- At least 2 years experience in the regulatory operations area, regulatory affairs will be an asset.
- A career path that will allow you to become a Subject Matter Expert
- The opportunity to work on different Pharmacovigilance/Regulatory processes across different projects
- Trainings on various competencies and skills
- Language courses and training
- On-site relax & gym rooms
- Volunteering, sport and employee events
+36 30 174 2006
+36 30 174 2006