Jr Manager Regulatory Submissions Maintenance EEA

3 weeks ago

Timișoara, Timiş, Romania STADA Hemofarm Full time

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.

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