Senior IND/IDE Regulatory Affairs Specialist
United StatesJust now
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Key details
- Location
- United States
- Work style
- Remote
- Level
- Senior
- Experience
- 7–10 yrs
- Function
- Legal & Compliance
- Focus area
- other
- Posted
- Just now
Skills
About the role
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
Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.