Regulatory Specialist

Title : Regulatory Specialist

Location : Bethesda, MD

Status : Full Time

Travel : Yes

Salary Range : $75,000 - $100,000

Position Summary :

The Regulatory Specialist provides regulatory affairs support for new and existing Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs) associated with intramural clinical research studies conducted by the National Human Genome Research Institute (NHGRI), part of the National Institutes of Health (NIH). This position is responsible for supporting the preparation, compilation, maintenance, and submission of regulatory documentation to the U.S. Food and Drug Administration (FDA), ensuring that applications and associated regulatory activities remain current, complete, and compliant with applicable regulatory requirements.

The Regulatory Specialist works closely with NHGRI investigators, clinical research teams, sponsors, and other regulatory stakeholders to coordinate IND and IDE submissions, amendments, annual reports, safety reports, and other required regulatory correspondence. Responsibilities include reviewing existing applications for completeness, identifying outstanding regulatory obligations, coordinating the transfer of INDs and associated responsibilities when necessary, and supporting the assessment and reporting of serious adverse events. The position also contributes to regulatory strategy and provides support for FDA meetings and communications, including the preparation of meeting requests, briefing materials, and follow-up documentation.

Through effective regulatory oversight, document management, and coordination with clinical research personnel, the Regulatory Specialist helps ensure the integrity and continuity of NHGRI-sponsored clinical research activities and supports the Institute's mission to advance genomics research and improve human health.

Duties/Responsibilities :

• Prepare, compile, and support submission of new and existing IND/IDE applications, amendments, transfers, and other required regulatory documents.
• Draft and assemble IND annual reports and safety reports, including cover letters, required FDA forms, and eCTD submission materials.
• Review existing IND files for completeness, identify overdue reports or outstanding FDA commitments, and prepare a gap analysis and plan to address deficiencies.
• Review serious adverse-event documentation and relevant study records to support assessment of event causality, expectedness, and applicable expedited reporting requirements, coordinating with qualified medical personnel as needed.
• Coordinate with investigators, sponsors, and NHGRI staff to track submission deadlines, obtain source information, and support regulatory meetings and reporting requirements.
• Other duties as assigned.

Minimum Requirements :

• Education: Bachelor's degree in life sciences, health sciences, nursing, pharmacy, regulatory affairs, or a related field. Equivalent education and experience may be considered.
• Relevant experience: Ideally, 3-5 years supporting FDA-regulated clinical research, preferably involving Investigational New Drug (IND) applications or Investigational Device Exemptions (IDEs).
• Regulatory submissions: Demonstrated experience preparing or compiling FDA submissions, including IND amendments, annual reports, safety reports, and supporting documentation.
• Regulatory knowledge and writing: Working knowledge of FDA submission requirements, clinical study documentation, adverse-event reporting, and regulatory correspondence.
• Experience with electronic Common Technical Document (eCTD) submissions is strongly preferred.

Benefits:

KIC offers a comprehensive benefits package to eligible full-time employees including: 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 Reimbursement, Employee Assistance Program, Employee Discount Program, and more!

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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. 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.