Job Summary
A global contract research organization is seeking a Remote Senior or Principal Regulatory Affairs Specialist.
Individual must be able to fulfill the following responsibilities:
- Mentor less experienced staff
- Provide senior review of regulatory submissions
Applicants must meet the following qualifications:
- May require travel of ~10%
- Familiar with computers and their applications, e.g. Word, Excel, Power Point
- Bachelor's degree and 5+ years of experience
- OR Equivalent combination of education, training, & experience
- Expert knowledge of ICH and other global regulatory guidelines
- In-depth knoweldge of one of the specialty areas: preclinical, clinical or CMC, etc
