Job Summary
A pharmaceutical and genetic research company needs applicants for an opening for a Remote Nonclinical Strategy Focus Gene Therapy Regulatory Affair Director.
Individual must be able to fulfill the following responsibilities:
- Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements
- Develop a global product regulatory strategy for the development of gene and cell therapy products
- Ensure timely and accurate submissions to Regulatory Authorities
Skills and Requirements Include:
- Bachelor's Degree in Pharmaceutical Sciences or general science field
- Understanding of overall process of drug development and the overall pharmaceutical R&D process is required
- In-depth knowledge with interaction with FDA and various types of US submissions
- 5+ years of experience in regulatory affairs or clinical pharmacology with gene therapy product experience
- Familiarity with clinical trial methodology and statistics
- Working knowledge of clinical and regulatory landscape, disease processes and mechanisms, etc
