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Regulatory Affairs Manager

Régió: Budapest

HAYS Hungary Kft.
Hozzáadva: 2014.08.09.
Jelentkezési határidő: 2014.10.01.
Hirdetés azonosító: 843911


Regulatory Affairs Manager
Regulatory Affairs Manager is sought by our global pharmaceutical assignor in Hungary!

The purpose of the role is to manage regulatory life-cycle of assigned portfolio and manage all regulatory related activities.

Key responsibilities:

- Manage and maintain regulatory documentation.
- Establish and maintain contact with Hungarian authorities and Global Regulatory Affairs.
- Review and approve translation of patient information leaflets and labelling materials.
- Ensure market approval of assigned portfolio and manage occasional regulatory projects in a timely manner.


- University degree in Pharmaceutical or Natural sciences
- At least 2-3 years experience in regulatory affairs in pharmaceutical industry
- Proven track record in assembly and/or evaluation of CTD document is desirable
- Good command of English and native Hungarian
- Attention to detail and multi-tasking ability
- Computer literacy

Please upload your CV to apply or contact Peter Sitte directly.
Munkavégzés helye: Budapest

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