Regulatory Consultant

Posted Yesterday
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Hiring Remotely in Moldova
Remote
Mid level
Biotech
The Role
Freelance regulatory consultant to proofread and adapt translated clinical trial labels to local requirements, review label printouts, approve documents, provide regulatory consulting for medicines (and preferably devices/IVDs), and interact with health authorities as needed. Ad hoc engagement (~1–2 hours/month) based in Moldova.
Summary Generated by Built In

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 Required

  • Knowledge of local legislation and regulatory requirements in the clinical trials field
  • Degree in medicine, pharmacy, life sciences, or related field
  • Excellent knowledge of English
  • Strong organizational, communication and teamwork skills
  • Accuracy and attention to detail
  • Computer literacy
  • Experience with regulatory consulting for medicines and preferably devices/IVDs
  • Ability to interact with health authorities when applicable
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The Company
HQ: Durham, North Carolina
793 Employees
Year Founded: 1984

What We Do

Changing what it means to work with a global CRO. At Rho, we believe expertise is everything. With team members spanning continents, we bring together the brightest minds in the industry. With a demonstrated track record of success, we guide our clients through the most appropriate program strategies, navigate the unique challenges of clinical trials, and drive development of the high-quality marketing applications demanded by regulatory authorities. Sparked by a shared mission to improve lives, our experts take clients beyond procedural operations and into truly proactive problem-solving. Through a collaborative approach and individualized attention, our focus is advancing your program so that, together, we can help heal the world. That is what drives us. Experience, Rho.

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