Tasks

- Coordination and tracking of Regulatory requests received from business partners in the APAC, LatAM and MENA regions
- Collaborate with the Regulatory Affairs Managers, and cross-functionally with the respective Project Leaders as well as CMC, QA, Supply Chain, and Alliance Managers, and Legal team members
- Communication of changes and status of EU variations to business partners
- Single point of contact for external vendors and tracking of partners’ regulatory assessment and submission status of the changes in the partners’ territories
- Compliant filing and archiving of Regulatory documents in the document management system
- Administrative Regulatory Affairs support
- eCTD publishing support

Qualifications

- 3 - 5 years of Regulatory Affairs Coordination/Assistance experience
- Team player with the motivation to work in a multi-cultural, dynamic and international setting, with cross-functional internal and external collaboration
- Ability to work independently, with the capacity to focus on several tasks in parallel
- Willing to develop personally within an agile organization
- Good communicator, well organized, with good planning skills
- Fluency in English essential, and any other language would be an asset