Saratoga Medical is hiring a
Remote, Senior IND/IDE Regulatory Affairs Specialist Package includes competitive rate and benefit options. Please see qualifications below and submit your resume if you are interested in being considered:
Education: Bachelor's degree in a scientific or related field required; advanced degree or RAC certification preferred.
Experience: Minimum of 7 years of regulatory affairs experience, including at least 5 years supporting FDA IND and/or IDE submissions.
Qualifications:- Preparation and review of IND/IDE applications, protocol amendments, information amendments and annual reports
- Preparation of IND safety reports and other expedited safety submissions
- Experience supporting FDA meetings, including pre-IND and other formal interactions, and managing regulatory correspondence
- Review and maintenance of regulatory files, essential documents and submission trackers
- Strong knowledge of FDA regulations and guidance applicable to investigator-sponsored studies
- Experience with gene therapy or other advanced therapeutic products is advantageous
- Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs
- Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA
- Current human subjects protections and GCP training (e.g., CITI or equivalent)
- Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials
