Regulatory Affairs Specialist – DoD Medical Programs

Goldbelt, Inc.; Maryland; Hybrid; USD 95,000 - 135,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Professional development

Job summary

Goldbelt Apex is seeking a Regulatory Affairs Support – WEMT to contribute to regulatory strategy and execution within the DoD medical acquisition framework. This role focuses on regulatory documentation, IND support, and cross-functional collaboration across therapeutics, diagnostics, and clinical programs.

You will coordinate FDA/IRB activities, lead IPTs, ensure compliance with cGCP, cGLP, cGMP and Title 21 CFR, and produce high-quality technical writing. Travel up to 20% may be required.

Qualifications

• Knowledge of cGCP, cGLP, cGMP and Title 21 CFR.
• Ability to support IND regulatory requirements.
• Strong technical writing and stakeholder coordination.
• Travel: Up to 20%

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
• Develop/review regulatory documentation.
• Coordinate FDA/IRB activities.
• Participate in and lead IPTs/working groups.
• Support IND product accountability, protocol management, technical reports, training, and stakeholder coordination.
• Investigational product/program management.
• FDA/IRB regulatory coordination.
• Clinical protocol management.
• GCP training and regulatory documentation.
• Stakeholder/IPT leadership.
• Product accountability and technical analysis.

Job description

Goldbelt Apex is seeking a Regulatory Affairs Support – WEMT to contribute to regulatory strategy and execution within the DoD medical acquisition framework. This role focuses on regulatory documentation, IND support, and cross-functional collaboration across therapeutics, diagnostics, and clinical programs.

You will coordinate FDA/IRB activities, lead IPTs, ensure compliance with cGCP, cGLP, cGMP and Title 21 CFR, and produce high-quality technical writing. Travel up to 20% may be required.