Regulatory Affairs Assistant
Alvogen
Bucureşti, Romania
36 zile în urmă

Job description :

  • Responsible for creating data rooms with SharePoint designed to exchange confidential data; granting access to external auditors, uploading documentation and ensuring technical support throughout the audit process
  • Maintain data on internal server by uploading the documentation and update the Database
  • Ensure that the internal trackers are timely updated
  • Quality review of the information against the content of submitted / approved dossiers
  • Prepare payment requests and monitor the invoices progress
  • Perform other administrative tasks related to general RA activities : responsible for DHL delivery of documents to the authorities, notarization / legalization of documents when needed
  • Ensure proper communication within the team and with other departments of the relevant information
  • Responsible for recording / archiving the incoming or outgoing documents
  • Requirements :

  • Bachelor’s degree required (preferable chemistry, biochemistry, biology, pharmacy)
  • English language : advanced level, both speaking and writing
  • Good IT skills, advanced skills in using Microsoft Office
  • Excellent organizational skills, attention to detail
  • Ability to work effectively without direct supervision but also as part of a team;Ability to analyse the different needs for each situation and identify the optimal solutions
  • Enthusiastic, proactive
  • Good communication skills
  • Attention to details and well organized
  • Teamwork spirit, also able to perform alone
  • Problem solving capacity and ability to think outside the box
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