Job Summary
A biotechnology company has an open position for a Remote Pharmaceutical Regulatory Affairs Director.
Core Responsibilities Include:
- Functioning as the regulatory lead for assigned projects
- Providing regulatory strategy, guidance and input throughout product clinical development
- Authoring and contributing to department operating procedures and work instructions
Qualifications for this position include:
- Master’s Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline
- 5 years for Associate Director (10 for Director) of clinical trial programming experience
- Experience in the biotechnology, pharmaceutical, or health related industry
- Advanced SAS programming skills and experience in other statistical software
- Experience and in-depth knowledge in CDISC
- Vendor management experience