IND/IDE Regulatory Lead — FDA Submissions & Strategy

Midnight Sun Global Services, LLC; 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

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.