Compliance Specialist

4 weeks ago


Fairfield, New Jersey, United States Solomon Page Full time

About the Role:

We are looking for a highly organized Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Team, you will be responsible for ensuring timely and compliant regulatory submissions.

Responsibilities:

  • Interact with cross-functional teams to procure documentation required for regulatory submissions
  • Review, manage, and write regulatory submissions electronically
  • Responsible for filing post-approval supplements, including CBE-0, CBE-30, and Prior Approval Supplements

Requirements:

  • Bachelor's degree in a scientific discipline
  • Minimum 2 years of experience in Regulatory Affairs or a related field
  • Strong understanding of ICH and FDA guidelines
  • Excellent communication and organizational skills

Why Work with Us:

Clinical Resource Network is a leading provider of clinical research and talent solutions. We offer a dynamic work environment and opportunities for professional growth and development.



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