Hemofarm STADA srl is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Romania, Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.
(Junior) Manager Regulatory Submissions non-EEA
Place of work: Timișoara
Contract: fixed period - 1 year (project based)
Contract: fixed period - 1 year (project based)
As (Junior) Manager Regulatory Submissions non-EEA you are part of the Regulatory Submissions Team in Global Regulatory Affairs. In close coordination with other functions, you will work on the successful maintenance of registrations for medicines in our global markets. As part of the team, you will actively contribute to the operational implementation of STADA's global regulatory strategies.
Requirements:
- Graduate in pharmacy, biology or a comparable field, or 2-3 years of professional experience in the field
- You think analytically, are process- and solution-oriented, work independently, in a structured and flexible manner, but always keep the desired goal in mind.
- You are a reliable team player.
- You have very good communication skills and you are fluent in written and spoken English..
- Ideally, you have already gained experience with software used in drug registration (databases, publishing and document management systems).
- Good organizational and in time management skills
- Relevant experience will be consider as advantage but it's not mandatory
Your duties would include:
- Responsible for the planning and implementation of regulatory life-cycle projects (“variations”) in the non-European region.
- Active contributions with your regulatory expertise in cooperation with interdisciplinary project teams.
- Creating, review and maintain documents required for regulatory life-cycle processes in target markets
- Responsibile for keeping regulatory database up to date
- Act as contact person at the interface with internal departments, subsidiaries and external partners.
- Coordinate the necessary activities in a regulatory and culturally heterogeneous environment.
What we offer:
- Attractive salary package
- Bonuses for Easter, company birthday, Christmas
- Performance bonus
- Transport allowance
- Meal vouchers
- Private medical insurance
- Modern working conditions with a young and dynamic team
Only shortlisted candidates will be contacted.
