Krka Magyarország Kft.

Törzskönyvezési munkatárs

Pest megye

Preparing the administrative part of the registration documentation of pharmaceutical products
Ensure and review the translations of Product Information into local language in accordance with legal and regulatory requirements
Submission and follow-up of registration documentation to local and European regulatory Agencies
Maintenance of Marketing Authorisations (variations, renewals) – preparation of required documentation and supporting the procedures during all phases
Populate and maintain Regulatory Databases/ensure timely implementation and compliance
Ensure full compliance to legal requirements and to internal procedures
Performing tasks related to the local quality system.

University degree in pharmaceutical sciences, chemistry or other life sciences
1-3 year relevant regulatory affairs experience is advantage
Excellent organization skills and ability to work on a number of projects with tight timeline
Good communication skills, sense of initiative, open-minded
Precise and analytical attitude
Excellent written and oral English skills
Collaborative approach and enjoy working in a team
Good level of PC skills (Word, Excel, PPT).

Cégnév:	Krka Magyarország Kft.
Állás helye:	Magyarország Pest megye
Állás-kategóriák:	Egészségügy / Gyógyszeripar Gyógyszerész Egészségügy / Gyógyszeripar Egyéb gyógyszeripari szakember
Állásnév:	Törzskönyvezési munkatárs

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