Job Summary
A staffing agency has a current position open for a Remote Pharmaceutical Senior Regulatory Affairs Specialist.
Core Responsibilities of this position include:
- Filling of Original ANDAs and NDAs applications
- Filling applications to the US FDA for sterile, injectable drug products
- Reporting directly to the Director of Regulatory Affairs
Skills and Requirements Include:
- Minimum of 4 years in Regulatory Affairs experience
- B.S. or M.S. in Engineering, Pharmaceutical, Chemistry or Biological Sciences
- Expertise in Pharmaceutical Regulatory and FDA process and interface
- Experience with submissions, ANDA and NDAs