Regulatory Specialist

1 day ago


Sydney, New South Wales, Australia Precision For Medicine Full time
{"title": "Regulatory and Start Up Specialist", "description": "Job Summary

We are seeking a highly experienced Regulatory and Start Up Specialist to join our team at Precision For Medicine. As a key member of our clinical operations team, you will be responsible for ensuring the successful start-up of clinical trials in assigned countries.

Key Responsibilities
  • Prepare and submit clinical trial applications to Competent Authorities and IRB/Ethics Committees
  • Coordinate the collection and review of essential documents required for site activation
  • Develop and maintain country-specific tools and guidance documents to ensure compliance with local and international regulations
  • Collaborate with site contract management to negotiate budgets and contracts
  • Provide training and support to junior staff on site start-up activities
Requirements
  • Bachelor's degree in life sciences or related field
  • Minimum 5 years of experience in regulatory or start-up activities
  • Excellent communication and organizational skills
  • Fluency in English and local language of country where position based
Preferred Qualifications
  • Relevant regulatory and site start-up experience for the particular country
  • Experience using milestone tracking tools/systems
  • Advanced degree in medical or life sciences/RAC certification

Why Join Us?

Precision For Medicine is a leading provider of clinical trial services. We offer a dynamic and supportive work environment, with opportunities for professional growth and development.

", "lang_code": "en-US"}

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