Regulatory Affairs

Staff position: Regulatory Affairs Coordinator

Job Description:

This position is responsible for providing Regulatory oversight of Clinical operations, supporting the implementation and maintenance of the Document Control and regulatory training development systems and ensuring compliance to applicable regulatory, FDA, and ICH guidelines/regulations. This position also supports the review of regulatory and clinical documents, as needed.

Responsibilities include, but are not limited to:

  • Assist with the conduct of routine audits of clinical files to ensure that regulatory documents are collected, updated and filed appropriately.
  • Ensure compliance with applicable FDA regulations and ICH guidelines
  • Ensure that regulatory and clinical documents are filed, scanned, and archived according to company SOPs, regulatory commitments, and sponsor obligations
  • Collaborate with project managers to ensure trial master file content and format are consistent, communicated and adhered to.
  • Support the creation, implementation, maintenance and improvement of hardcopy and electronic filing systems for the retention of all clinical trial documents.
  • Assist Head of QA with the preparation, review, tracking and maintenance of regulatory and clinical documents.
  • Review documentation as needed to support regulatory filings
  • Assist with the creation and revision of controlled documents to support and improve quality systems.
  • Support, maintain, and improve QA training development systems.
  • Provide clinical-specific training to company personnel.
  • Assist in training company personnel on other QA aspects, as needed.