Regulatory Affairs Support Specialist

Job overview

The Regulatory Affairs Support Specialist role is hybrid in Frederick, MD. Compensation is not specified; the posting lists pay as TBD. The position supports the Defense Health Agency and helps advance military medical technologies from development toward deployment. The specialist supports regulatory submissions, FDA interactions, and compliance activities for drugs, biologics, blood products, medical devices, and other medical solutions. By coordinating documentation, regulatory research, and cross-functional schedules, the role helps teams manage regulatory requirements and program milestones.

What you'll do

• Support regulatory strategies and lifecycle activities
• research and summarize FDA regulations, guidance, policies, and standards
• assist with preparing, reviewing, formatting, and maintaining regulatory submissions
• coordinate documentation, stakeholder inputs, quality reviews, version control, and submission readiness
• support agency meetings and communications
• assist with regulatory gap analyses
• maintain regulatory files and trackers
• communicate status, deadlines, risks, and action items
• support integrated plans and schedules for regulatory and clinical activities.

What we're looking for

Skills & competencies

regulatory affairs support specialist

regulatory submissions

fda regulations

medical devices

drugs and biologics

compliance

defense health agency

frederick md

ctc

hybrid

u.s. citizenship required

pay tbd

Work arrangement

• Weekend coverage required

Benefits & perks

• The posting describes comprehensive benefits, competitive compensation, bonus and award programs, and professional growth opportunities.

Why this role

Requires at least four years of relevant experience, including support for DoD, DHA, federal healthcare, acquisition, or program-management organizations; U.S. citizenship is required. A relevant bachelor’s degree is preferred.

About the employer

CTC is hiring for this role. Industry: Custom Computer Programming Services. Sector: 54.