Regulatory And Site Start Up Specialist

Precision for Medicine

Hong Kong
Remote
Clinical trial application submission
Irb/ec interaction and responses
Essential document collection and review
Precision for Medicine is seeking a Regulatory and Site Start-Up Specialist based in Hong Kong, focusing on regulatory submissions and site activation for clinical trials. The role requires strong communication and organizational skills, with a preference for candidates with prior experience in the CRO or pharmaceutical industry

Job Summary

  • The role involves preparing and submitting Clinical Trial Applications to Competent Authorities and Ethics Committees to obtain necessary authorizations for conducting clinical trials.
  • The specialist acts as a Subject Matter Expert to guide other team members on country-specific regulatory requirements and ensures compliance with ICH-GCP guidelines.
  • Responsibilities include customizing patient information sheets, coordinating translations, and supporting budget and contract negotiations to secure timely site activation.

Matching Summary

Match Score: 85

Precision for Medicine is seeking a Regulatory and Site Start-Up Specialist based in Hong Kong, focusing on regulatory submissions and site activation for clinical trials. The role requires strong communication and organizational skills, with a preference for candidates with prior experience in the CRO or pharmaceutical industry.

Skills & Requirements

Must-have

  • Clinical Trial Application submission
  • IRB/EC interaction and responses
  • Essential document collection and review
  • Informed Consent Form customization
  • Site activation readiness delivery
  • Regulatory intelligence maintenance

Nice-to-have

  • Subject Matter Expertise in local regulations
  • Process improvement initiative participation
  • Mentoring and training capabilities
  • Advanced degree in medical sciences
  • RAC certification or Masters in Regulatory Science

Key Requirements

  • Bachelor's degree in life sciences or Registered Nurse
  • 1+ year experience as Regulatory or Site Start Up Specialist
  • Fluency in English and local language of Hong Kong

Work Rights

Not specified

Tailored Resume

Cover Letter