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Posted 15 months ago

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Regulatory Consultant

MoldovaRemoteContract

AI Summary

A Regulatory Consultant proofreads translated labels, conducts regulatory reviews and local adaptations, and consults on clinical trial-related matters to ensure compliance with local requirements.

About this role

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career. With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

We are currently hiring a Freelance Regulatory Consultant to join us in Moldova. This will be ad hoc work with approximately 1 - 2 hours work required per month.

Responsibilities:

  • Proofreading of translated label by checking the correctness of the translation, its spelling and grammar, text completeness, storage conditions;
  • Regulatory review and local adaptation of translated label according to local regulatory requirements;
  • Proofreading and regulatory review of label printouts;
  • Approval of document by signing each page of document
  • Regulatory consulting on various clinical trial related aspects (medicines and preferably devices/IVDs) in countries concerned;
  • Interactions with Health Authorities, if applicable.

Requirements

  • Knowledge in local legislation and regulatory requirements in clinical trials field
  • Degree in medicine, pharmacy, life science or related field will be considered as advantage
  • Excellent knowledge of English language
  • Strong organizational, communication and teamwork skills
  • Accuracy and attention to details
  • Computer literacy

Skills

Clinical ResearchClinical Trial RegulationsComputer LiteracyDocument ProofreadingHealth Authority InteractionsLabel Review And AdaptationRegulatory Compliance

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