28 Mar
Regulatory Affairs Assistant / Regulatory Officer
Georgia, Tbilisi 00000 Tbilisi USA

Vacancy expired!

Job Description

Join our team of experts in regulatory and ethics submissions of clinical studies.You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.

Office-based in Tbilisi, Georgia

Your role:

  • Be the point of contact for clinical project teams and support services on regulatorymatters
  • Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications
  • Be responsible for document management such as filing, processing,translation, quality control
  • Update and maintain (automated)tracking systems, working files,and schedules
  • Communicate with regulatory authorities, ethics committees, project teams and vendors on regulatory-related matters
  • Review translations of essential documents subject to clinical trial submission
  • Review documents to "greenlight" IP release to sites
  • Manage safety reporting to authorities
  • Deliver regulatory training to project teams
  • Assist with feasibility research and business development requests
  • Organize meetings, prepare agendas and minutes

Qualifications

  • Prior experience in clinical research industry
  • Legal background and prior exposure to Regulatory Affairs is a plus
  • Excellent command ofEnglish and Georgian
  • College/University degree
  • Proficiency in MS Office applications
  • Attention to detail
  • Ability to face challenges and communicate at all levels to achieve results
  • Collaboration and problem-solving skills

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then this is the right choice for you.

Vacancy expired!


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