Hemofarm STADA is a member of the STADA group, one of the world's largest generic pharmaceutical companies, which successfully operates in the markets of Serbia and the Western Balkans. Hemofarm produces high-quality pharmaceutical products within the leading pharmacotherapeutic groups, respecting key corporate values:  Agility, Integrity, Entrepreneurship and ONE STADA.

Junior Manager Regulatory Submissions Maintenance EEA

Place of work: Timisoara

About Job

We are currently seeking a dedicated and self-motivated individual to join our team as a Junior Manager Regulatory Submissions Maintenance for the EEA (European Economic Area). As a member of our Regulatory Affairs team, you will play a crucial role in ensuring compliance with regulatory requirements and facilitating the maintenance and life-cycle activities for medicinal products within the EEA market.

Key responsibilities:

• Independently prepare and submit maintenance- and life-cycle activities for medicinal products, including variations, renewals, and PSUR submissions.
• Coordinate projects, making project-related decisions, and providing regular reporting on progress.
• Liaise with project teams, both internally and externally, to ensure smooth coordination and collaboration.
• Prepare, review, revise, and maintain regulatory documents in accordance with EEA regulations.
• Monitor internal and external deadlines to ensure timely completion of regulatory tasks.
• Administer data in regulatory databases accurately and efficiently.

Requirements:

• University degree or professional education with relevant Regulatory Affairs (RA) experience.
• Demonstrated ability to work independently and take ownership of tasks.
• Strong team player with excellent communication and social skills.
• High level of responsibility and accountability.
• Reliable and adaptable personality with a flexible approach to work.
• Knowledge of the legal framework for Regulatory Affairs for medicinal products in the EEA is adventage
• Proficiency in English, both written and verbal.