Master's, Ph.D., or PharmD in a life science field (Bachelor's with additional experience acceptable)
10 years of regulatory affairs experience with INDs and IDEs
Experience preparing sponsor-investigator INDs, including Forms FDA 1571 and 1572
Experience with IND annual reports, safety reports, amendments, and IND transfers
Experience leading formal FDA meetings (Type B, Type C, or pre-NDA)
Working knowledge of eCTD submission format
Preferred: Regulatory Affairs Certification (RAC) and experience with gene and cell therapy INDs
Responsibilities
Complete a gap analysis of every IND and IDE within 30 days, addressing deficiencies
Maintain open applications to ensure no outstanding reports or FDA commitments
Direct preparation of 12 IND annual reports and conduct sponsor calls before each IND anniversary
Prepare new sponsor-investigator IND and IDE submissions with the clinical study team
Review INDs before transferring to pharmaceutical partners and draft FDA transfer submissions
Lead the strategy and execution of the Proteus FDA meeting
Serve as the point of contact for FDA correspondence and support on-site review of non-electronic IND records
Supervise the Regulatory Affairs Specialist / eCTD Publisher
Benefits
Full-time position with local travel opportunities
Opportunity to lead a significant IND and IDE portfolio
Engagement with FDA processes and formal meetings
Collaboration with clinical study teams and pharmaceutical partners
Supervisory role over regulatory affairs staff
Potential for professional development in regulatory affairs certifications
Full Job Description
Title: Regulatory Affairs Lead (IND/IDE) Location: Bethesda, MD Status: Full Time Travel: Yes, local travel Salary Range: $80,000 - $115,000
Position Summary:
The Regulatory Affairs Lead owns NHGRI's IND and IDE portfolio, now held by the Institute rather than individual investigators. The portfolio is about 40 INDs and 12 IDEs under OCD, plus the Proteus syndrome IND. The role leads the 30-day gap analysis, annual report and submission strategy, IND transfers, and the formal FDA meeting for the Proteus program.
Duties & Responsibilities:
Complete a gap analysis of every IND and IDE named in a task order within 30 calendar days, with a plan to fix any deficiencies
Maintain each open application so there are no outstanding reports or FDA commitments
Direct preparation of about 12 IND annual reports and other submissions per year, and hold sponsor calls one month before each IND anniversary
Prepare new sponsor-investigator IND and IDE submissions with the clinical study team
Review each IND before transferring to a pharmaceutical partner and draft the FDA transfer submission
Lead the Proteus FDA meeting: strategy, timeline, meeting request, briefing package, participation, and follow-up
Serve as the JV's point of contact for FDA correspondence and support on-site review of non-electronic IND records when required
Supervise the Regulatory Affairs Specialist / eCTD Publisher
Minimum Requirements:
Master's, Ph.D., or PharmD in a life science field (a Bachelor's with additional experience is acceptable)
10 years of regulatory affairs experience with INDs and IDEs
Experience preparing sponsor-investigator INDs, including Forms FDA 1571 and 1572 and the Introduction and General Investigational Plan
Experience with IND annual reports, safety reports, amendments, and IND transfers to industry partners
Experience leading formal FDA meetings (Type B, Type C, or pre-NDA), including meeting requests and briefing packages
Working knowledge of eCTD submission format
Preferred: Regulatory Affairs Certification (RAC); institutional or academic sponsor IND portfolios (NIH or academic medical center); gene and cell therapy INDs, including AAV vector and CMC content; device IDEs; rare pediatric disease designations
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Disclaimer:
This is not to be an exclusive list of all responsibilities, duties, and skills required of the person in this job. The salary range for this position is based on several factors, including relevant experience, education, skills, and current market conditions.
