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  • Regulatory Affairs/Quality Assurance Specialist Bucharest
  • STADA in Bucharest, , Romania
  • jobs
  • 2 weeks ago

jobs description

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
Bucharest Romania

salary-criteria

Apply - Regulatory Affairs/Quality Assurance Specialist Bucharest