• Regulatory Affairs Specialist (Romania) Bucharest
  • Biomapas in Bucharest, , Romania
  • jobs
  • 4 weeks ago

jobs description

Join our global team as a Regulatory Affairs Specialist.

Regulatory Affairs Specialist is responsible for assigned projects and related tasks, applications and dossiers submissions, communication with clients and national authorities.

Position is office based in Romania, Bucharest.


• Manage registration related activities mainly for Romania and EU

• Compile and submit applications for registration, renewals, variations in accordance to the national and EU legislation

• Interact with regulatory authorities, client representatives

• Regulatory review of promotional materials

• Translate/update the specific Product Information

• Review/proofread of artworks

• Support on standard procedures development

• Participate in audits

• Update/collect information on regulatory requirements and instructions

• University degree in Life Science field

• Fluent English language and Romanian language

• 2-4 year’s experience in Regulatory Affairs with medicinal...
Bucharest Romania


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