Senior Regulatory Affairs SME — FDA/DoD Pathways Lead

General Dynamics Information Technology, Inc.; Frederick (MD); Hybrid; USD 94,000 - 127,000; Full time

Benefits offered by this job

Full-flex work week

401K with company match

Comprehensive health and wellness

Internal mobility support

Professional growth opportunities

Cutting-edge technology

Paid vacation and holidays

Job summary

GDIT seeks a senior Regulatory Affairs SME to lead regulatory strategy for medical product development and acquisition programs within the Portfolio Acquisition Executive for Medical Products. You will advise on regulatory requirements, coordinate agency interactions, and ensure FDA, DHA, and international compliance throughout the product lifecycle.

You will work with Product Managers, IPTs, and senior leadership to develop regulatory strategies, review submissions, and manage risks and

Qualifications

• Bachelor’s degree in Regulatory Affairs, Biology, Chemistry, Biomedical Sciences, Pharmacy, Public Health, Engineering, or a related scientific discipline.
• Minimum ten (10) years of progressively responsible regulatory affairs experience in pharma/biologic/medical device/blood products or related fields.
• Must have current and active Regulatory Affairs Certification (RAC).
• Strong knowledge of FDA regulatory requirements, submission processes, and lifecycle management.

Responsibilities

• Serve as primary regulatory affairs advisor for assigned programs.
• Provide guidance on regulatory requirements for drugs, biologics, devices, and diagnostics relevant to military medicine.
• Develop regulatory strategies supporting product development and lifecycle management.
• Interpret FDA regulations and communicate impacts to stakeholders and leadership.
• Prepare and support regulatory submissions (INDs, NDAs, PMAs, 510(k)s, technical files, reports).
• Coordinate interactions with FDA and other authorities, including meetings and responses.
• Review clinical and regulatory documents to ensure compliance and inform decisions.
• Collaborate with cross-functional teams to ensure lifecycle regulatory compliance.
• Develop and maintain Integrated Master Plans and schedules for regulatory activities.

Skills

Compliance requirements

FDA regulatory requirements

International regulatory compliance

Research and development

Education

Bachelor’s degree in regulatory affairs or related field

Job description

GDIT seeks a senior Regulatory Affairs SME to lead regulatory strategy for medical product development and acquisition programs within the Portfolio Acquisition Executive for Medical Products. You will advise on regulatory requirements, coordinate agency interactions, and ensure FDA, DHA, and international compliance throughout the product lifecycle.

You will work with Product Managers, IPTs, and senior leadership to develop regulatory strategies, review submissions, and manage risks and