Regulatory Affairs Subject Matter Expert (SME)

General Dynamics Information Technology • Fort Detrick, MD

10d • $93,500 - $126,500 • Hybrid

About The Position

The Regulatory Affairs Subject Matter Expert (SME) provides senior-level regulatory leadership, technical expertise, and strategic guidance to medical product development and acquisition programs within the Portfolio Acquisition Executive for Medical Products (PAE MP). The SME serves as the principal advisor on regulatory requirements, policies, and pathways for the development, testing, approval, and lifecycle management of drugs, biologics, blood and blood products, medical devices, diagnostics, and other regulated medical solutions.

The SME supports Product Managers, Program Managers, Integrated Product Teams (IPTs), and senior leadership by developing regulatory strategies; advising on risks and opportunities; coordinating agency interactions; reviewing scientific and clinical documentation; and ensuring compliance with applicable FDA, Department of War (DoW), Defense Health Agency (DHA), and international regulatory requirements. The role supports acquisition and product development from concept through approval, fielding, and sustainment.

The position requires a bachelor's degree in a relevant scientific or related discipline, at least ten years of progressively responsible regulatory affairs experience supporting regulated healthcare product development, and a current, active Regulatory Affairs Certification (RAC). The role is hybrid at Fort Detrick, Maryland, with a 40-hour scheduled workweek and less than 10% travel. The likely salary range is $93,500–$126,500, subject to experience, geographic location, and contractual requirements.

Requirements

• Bachelor's degree in Regulatory Affairs, Biology, Chemistry, Biomedical Sciences, Pharmacy, Public Health, Engineering, or a related scientific discipline.
• At least 10 years of progressively responsible regulatory affairs experience supporting pharmaceutical, biologic, medical device, blood product, combination product, or other regulated healthcare product development programs.
• Demonstrated experience developing and implementing regulatory strategies.
• Demonstrated experience with FDA regulatory pathways and submission processes.
• Demonstrated experience developing and reviewing regulatory submissions.
• Demonstrated experience with regulatory agency interactions and communications.
• Demonstrated experience with clinical and nonclinical product development programs.
• Demonstrated experience with product lifecycle management in regulated environments.
• Demonstrated experience participating in and leading multidisciplinary project teams.
• Current and active Regulatory Affairs Certification (RAC).
• Extensive knowledge of FDA requirements for drugs, biologics, blood products, medical devices, diagnostics, and combination products.
• Strong understanding of medical product development lifecycle activities and associated regulatory requirements from concept through commercialization and sustainment.
• Knowledge of current Good Clinical Practices (cGCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (cGMP).
• Knowledge of FDA regulatory frameworks, guidance documents, and compliance requirements applicable to product development programs.
• Excellent analytical, critical thinking, technical writing, and communication skills.
• Ability to evaluate complex scientific, clinical, manufacturing, and regulatory information and formulate strategic recommendations.
• Ability to independently manage multiple regulatory activities while collaborating with cross-functional teams.
• Strong organizational and project management skills.
• Advanced proficiency with Microsoft Office 365 applications, including Word, Excel, PowerPoint, Teams, SharePoint, and Project.
• Must be eligible to obtain and maintain personnel security requirements applicable to the contract and assigned duties.
• U.S. citizenship required.

Nice To Haves

• Master's degree in a scientific, medical, engineering, regulatory, or healthcare-related discipline.
• Experience supporting DoW, DHA, military medical research, acquisition, or product development programs.
• Experience supporting investigational medical products, medical countermeasures, blood products, trauma care products, or operational medicine programs.
• Experience participating in FDA meetings and regulatory negotiations.
• Familiarity with DoD acquisition frameworks and medical product acquisition processes.
• Experience supporting development of Integrated Master Schedules and product development roadmaps.

Responsibilities

• Serve as the primary regulatory affairs advisor and subject matter expert for assigned medical product development and acquisition programs.
• Provide regulatory guidance for drugs, biologics, blood and blood products, medical devices, diagnostics, and other regulated medical solutions relevant to military medicine and Warfighter health.
• Develop, evaluate, and implement regulatory strategies for product development, clinical development, regulatory submissions, and lifecycle management.
• Interpret FDA regulations, guidance, directives, industry standards, and policies, and explain their implications to stakeholders and leadership.
• Prepare, review, and support regulatory submissions and documentation, including INDs, NDAs, PMAs, 510(k) submissions, technical files, clinical evaluation reports, meeting materials, audit and inspection reports, and regulatory correspondence.
• Coordinate interactions with FDA and other regulatory authorities, including meeting preparation, sponsor communications, response development, and regulatory commitment management.
• Review scientific summaries, progress reports, clinical protocols, investigator brochures, safety reports, and surveillance data for regulatory compliance and product development decisions.
• Conduct regulatory gap analyses of processes, procedures, and documentation against applicable requirements and industry standards.
• Collaborate with clinical, research and development, manufacturing, quality, acquisition, logistics, and operational stakeholders to ensure lifecycle regulatory compliance.
• Assist with planning and execution of preclinical and clinical development programs and advise on milestones and submission requirements.
• Develop and maintain Integrated Master Plans and Integrated Master Schedules for regulatory and clinical development activities, milestones, deliverables, and timelines.
• Monitor evolving regulatory requirements and industry trends and communicate implications to program teams and leadership.
• Prepare and deliver briefings, technical assessments, decision papers, regulatory analyses, and recommendations for Government leadership and IPTs.
• Provide training, mentoring, and technical guidance on regulatory requirements, best practices, and product development processes.
• Advise Product Managers, IPTs, and senior leadership on regulatory risks, opportunities, compliance issues, and mitigation strategies.
• Support portfolio-wide regulatory strategy development to optimize medical product development and acquisition efforts.

Benefits

• 401(k) with company match.
• Comprehensive health and wellness packages, including medical plan options, some with Health Savings Accounts, dental plans, and vision plans.
• Paid education and certifications.
• Paid vacation and holidays.
• Paid time off plans including vacation, sick and personal time, paid parental leave, military leave, bereavement leave, and jury duty leave.
• Short- and long-term disability benefits.
• Life, accidental death and dismemberment, personal accident, critical illness, and business travel and accident insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior