Compliance Specialist
4 weeks ago
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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