Job Summary
A medical research and drug development company has an open position for a Telecommute Regulatory Affairs Operations Associate Director in Plano.
Must be able to:
- Coordinate regulatory submissions
- Oversee technical aspects for submissions
- Serve as lead publisher for in-house publishing
Skills and Requirements Include:
- BA/BS, MS, or PhD in relevant technical discipline
- Extensive knowledge of IND/NDA/eCTD and other electronic requirements and guidelines
- 8 years of highly relevant pharmaceutical /biotechnology experience in Regulatory Affairs
- Experience in working with vendors in support of regulatory submissions
- Knowledge and understanding of applicable global regulations
- Solid computer and organizational skills
