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12.11.2019

Regulatory Affairs Specialist

PSI
Фармацевтика
  • Регион:Киев
Английский (продвинутый)

Company Description

 

We're over 1,800+ strong across the globe. We're scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for Teamwork across all our business. We love the challenge of our industry. We're changing lives and redefining success every step of the way.

 

Job Description

 

What do you know about managing regulatory aspects of clinical studies? Do you have experience in the clinical research, trials, or biotech industry? Start a career with PSI as a Regulatory Affairs Specialist.

 

Office-Based in Kyiv

 

The scope of responsibilities will include:

 

  • Liaising with clinical project teams to procure documents required for regulatory & ethics submissions
  • Preparation of regulatory and ethics committee submission dossiers
  • Tracking regulatory project documentation flow and progress reporting
  • Tracking changes/amendments to legislation requirements related to clinical research
  • Maintaining the database of regulatory requirements
  • Communication point for ethics committees and regulatory authorities; ensuring accurate and timely reporting to authorities
  • Communication line for clinical Project Teams and PSI support services on regulatory matters

 

Qualifications:

 

  • Technical expertise in managing regulatory aspects of clinical studies and knowledge of local regulatory environment
  • Experience in Clinical Research is preferred
  • University degree in Life Sciences or Pharmacy or MD is preferred
  • Excellent command of English (spoken and written)
  • Excellent communication, planning, and organizational skills
  • Demonstrated ability to multi-task and work effectively in a fast-paced environment
  • Proficiency in standard MS Office applications

 

We offer:

 

  • Competitive salary and benefits package
  • Extensive training
  • Friendly team
  • Opportunities for personal and professional growth
  • High-quality standards and well-established infrastructure