Join the STADA Romania team!
"Caring for People's Health as a Trusted Partner" - is our mission that currently motivates over 12,300 employees globally.
In Bucharest we are looking for a new colleague as :
Regulatory Affairs/Quality Assurance Specialist
Key Responsabilities :
-Submission of all the necessary documentation for medicinal products related to new MA applications, variations, renewals, marketing authorization transfers, design change, Food Supplements notifications/label change notification
- Ensure the standards in supporting of all Regulatory applications in order to achieve an appropriate assessment
- Communicate with the competent authorities
- Provide Regulatory support to internal and external collaborators
- Keeping the Regulatory database up to date in accordance with the guidelines and legislation
- Responsible for planning, preparing, implementing and verifying the quality management system;
- Development and update the quality management system documents;
- Preparation and review of internal procedures
- Knowledge and compliance with the legislation regarding stored as well as the internal rules
- maintaining professional relations with partners.
What we are looking for :
- Degree in Pharmacy, Chemistry, Bio-Chemistry
- Minimum 1 year Regulatory/Quality experience
Join OneSTADA team !