Head of Compliance and Regulatory

2 weeks ago


Ambler, Pennsylvania, United States Exegenesis Bio Inc Full time
Job Summary

This senior-level position involves leading global regulatory affairs efforts for Exegenesis Bio Inc. The successful candidate will have extensive knowledge of clinical development, FDA, and international global clinical trial regulations, as well as ICH GCP guidelines.

Key Responsibilities
  • Develop and implement comprehensive regulatory strategies and processes to ensure timely and effective submissions.
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
  • Provide strategic guidance on regulatory matters, including market access and reimbursement strategies.

Requirements:

  • A PharmD or PhD degree in a scientific discipline and a minimum of 10 years of pharmaceutical and drug development regulatory experience.
  • Extensive knowledge of clinical development, FDA, and international global clinical trial regulations, as well as ICH GCP guidelines.
  • Demonstrated ability to manage complex regulatory projects and deliver against timelines.
Compensation and Benefits
  • $220,000 - $280,000 per year, depending on experience.
  • A comprehensive benefits package, including medical, dental, and vision insurance.
  • A generous 401(k) matching program.


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