Regulatory Affairs Lead (IND/IDE)

Kikiktagruk Inupiat Corporation; Bethesda (MD); On-site; USD 80,000 - 115,000; Full time

Job summary

Midnight Sun Global Services, LLC in Bethesda, MD seeks a Regulatory Affairs Lead to own NHGRI's IND/IDE portfolio, including about 40 INDs and 12 IDEs and the Proteus IND. You will coordinate the 30‑day gap analysis, annual reports, and FDA meeting strategy.

The role requires a life‑science master’s/PhD/PharmD (Bachelor plus experience acceptable) and at least 10 years in regulatory affairs with INDs/IDEs, plus eCTD knowledge; RAC is preferred.

Qualifications

• Advanced degree in life sciences required or equivalent with extensive regulatory experience.
• Minimum of 10 years in regulatory affairs with INDs and IDEs.
• Experience preparing sponsor-investigator INDs and FDA meetings; knowledge of eCTD.
• Regulatory Affairs Certification (RAC) preferred; strong cross-functional collaboration.

Responsibilities

• Own NHGRI's IND/IDE portfolio; lead gap analyses and submission strategy.
• Prepare IND annual reports, safety reports, and sponsor calls with timelines.
• Direct preparation of IND/IDE submissions with clinical study teams.
• Review IND transfers and draft FDA transfer submissions.
• Lead Proteus FDA meeting strategy, timeline, briefing package, and follow-up.
• Serve as primary контакт for FDA correspondence and on-site reviews.

Skills

Regulatory affairs

IND/IDE experience

eCTD knowledge

Leadership

Education

Life science master's/PhD/PharmD

Bachelor's + experience acceptable

Tools

FDA submission process

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

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.