IND/IDE Regulatory Specialist – FDA Submissions

Midnight Sun Global Services, LLC; Bethesda (MD); On-site; USD 75,000 - 100,000; Full time

Benefits offered by this job

Medical, Dental, and Vision Insurance

401k with Match

Life and ADD Coverage

Short and Long Term Disability

Paid Time Off and Holidays

Education Assistance/Tuition Reimburse

Employee Assistance Program

Employee Discount Program

and more!

Job summary

NHGRI in Bethesda, MD seeks a Regulatory Specialist to support IND/IDE regulatory activities for intramural clinical research. You will help prepare and submit regulatory documents to the FDA, ensure compliance, and coordinate with investigators and sponsors.

The role emphasizes maintaining current regulatory obligations and contributing to regulatory strategy. The position requires a life sciences degree and 3–5 years of FDA-regulated clinical research experience, with strong writing and

Qualifications

• Bachelor's degree in life sciences or related field.
• 3–5 years' experience in FDA-regulated clinical research (IND/IDE).
• Experience preparing FDA submissions (IND amendments, annual reports, safety reports).
• Working knowledge of FDA submission requirements and regulatory correspondence.
• Experience with electronic Common Technical Document (eCTD) submissions preferred.

Responsibilities

• Prepare and support submission of new and existing IND/IDE applications and amendments.
• Draft IND annual and safety reports with required forms and eCTD materials.
• Review IND files for completeness and identify overdue reports or commitments.
• Review serious adverse-event documentation and coordinate with medical personnel.
• Coordinate with investigators, sponsors, and NHGRI staff to track deadlines and support regulatory meetings.

Skills

Regulatory submissions

Regulatory writing

FDA regulations

eCTD submissions

Regulatory coordination

Education

Bachelor's degree in life sciences or related field

Tools

eCTD submissions

Job description

NHGRI in Bethesda, MD seeks a Regulatory Specialist to support IND/IDE regulatory activities for intramural clinical research. You will help prepare and submit regulatory documents to the FDA, ensure compliance, and coordinate with investigators and sponsors.

The role emphasizes maintaining current regulatory obligations and contributing to regulatory strategy. The position requires a life sciences degree and 3–5 years of FDA-regulated clinical research experience, with strong writing and