Regulatory Affairs Lead (IND/IDE) in Bethesda, Maryland at Kikiktagruk Inupiat Corporation, LLC

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

Apply online at our website: https://kikiktagruk.applicantpool.com/

Disclaimer:

This is not to be an exclusive list of all responsibilities, duties, and skills required of the person in this job. KIC is an Equal Opportunity Employer as to all protected groups, including protected veterans and individuals with disabilities. Pursuant to The Alaska Native Claims Settlement Act 43 U.S.C. Sec. 1601 et seq., and federal contractual requirements, Kikiktagruk Inupiat Corporation may legally grant certain preference in employment opportunities to KIC Shareholders and their Descendants. Successful candidates must adhere to KIC's Drug and Alcohol policy/testing requirements and may be required to pass a background and/or Motor Vehicle Records check. The salary range for this position is based on several factors, including relevant experience, education, skills, and current market conditions.