Regulatory Consultant

5 months, 3 weeks ago
Contract
Mid Level
Legal
Rho

Rho

Rho is a full-service Contract Research Organization (CRO) that combines innovation and scientific rigor to maximize results in every phase of clinical research. With a global team of experts, Rho ensures consistent and efficient trials, offering compr...

Biotechnology
251-1K
Founded 1984

Description

  • Proofread translated labels for translation accuracy, spelling, grammar, text completeness, and correct storage conditions.
  • Perform regulatory review and locally adapt translated labels to meet local regulatory requirements.
  • Proofread and conduct regulatory review of label printouts.
  • Approve documents by signing each page of the document.
  • Provide regulatory consulting on clinical-trial-related aspects for medicines and, preferably, devices/IVDs in the countries concerned.
  • Interact with Health Authorities when applicable.

Requirements

  • Knowledge of local legislation and regulatory requirements in the clinical trials field.
  • Degree in medicine, pharmacy, life sciences or a related field (considered an advantage).
  • Excellent knowledge of the English language.
  • Strong organizational, communication, and teamwork skills.
  • High accuracy and attention to detail.
  • Computer literacy.
  • Based in Moldova or eligible to work in Moldova.
  • Availability for ad hoc work at approximately 1–2 hours per month.
  • Experience with medical devices/IVDs (preferred).
  • Experience interacting with Health Authorities (preferred).

Interested in this position?

Apply directly on the company website

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