Regulatory Consultant

New
R
RhoClinical Research
MoldovaContract
Salary not disclosed
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Job Details

Languages
Excellent knowledge of English language

Requirements

  • Knowledge in local legislation and regulatory requirements in the clinical trials field.
  • Degree in medicine, pharmacy, life science or related field (advantageous).
  • Excellent knowledge of English language.
  • Strong organizational, communication and teamwork skills.
  • Accuracy and attention to details.
  • Computer literacy.

Responsibilities

  • Proofread translated labels by checking the correctness of the translation, spelling, grammar, text completeness, and storage conditions.
  • Perform regulatory review and local adaptation of translated labels according to local regulatory requirements.
  • Execute proofreading and regulatory review of label printouts.
  • Approve documents by signing each page.
  • Provide regulatory consulting on clinical trial related aspects including medicines, devices, and IVDs.
  • Manage interactions with Health Authorities where applicable.
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