Regulatory and Site Start Up Specialist

Added
12 days ago
Location
Type
Full time
Salary
Salary not provided

Related skills

regulatory affairs tmf ich-gcp site activation clinical trial applications

📋 Description

  • Deliver site activation readiness for assigned country/sites; mitigate risks.
  • Prepare Clinical Trial Applications and submission dossiers to authorities per local requirements on time.
  • Interact with CA/EC and respond to queries.
  • Provide regular updates to Start Up Lead, Regulatory Lead, and Project Team.
  • Maintain project plans, trackers, and regulatory tools.
  • Support start-up plans, IMP release needs, and document review.

🎯 Requirements

  • Bachelor's degree in life sciences or RN, or equivalent.
  • Pharmacy qualification or pharmacist experience beneficial.
  • 1+ year in regulatory or start-up roles in CRO or pharma.
  • Strong communication and organizational skills.
  • Experience with computerized systems, spreadsheets, word processing, and email.
  • Fluency in English.

🎁 Benefits

  • Equal Opportunity Employer.
  • Collaborative, value-driven culture.
  • Impactful work in cancer therapies.
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