Job Summary
A clinical research organization is filling a position for a Remote Regulatory Affairs Specialist.
Candidates will be responsible for the following:
- Leading in the preparation of regulatory documents
- Preparing and reviewing the documentation required
- Leading cross-functional review of documents/deliverables
Applicants must meet the following qualifications:
- College graduate in scientific, medical, clinical discipline or related field, or related experience
- 3 years’ experience in Regulatory Affairs or similar field
- Expert knowledge of scientific principles and concepts
- Proficiency with MS Office applications
- Understanding of CROs and scientific & clinical data/terminology, & the drug development process
