Regulatory Affairs Subject Matter Expert (SME)

Position Summary

The Regulatory Affairs Subject Matter Expert (SME) provides senior-level regulatory leadership, technical expertise, and strategic guidance in support of medical product development and acquisition programs within the Portfolio Acquisition Executive for Medical Products (PAE MP). The SME serves as the organization's principal advisor on regulatory requirements, policies, and pathways governing 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 regulatory risks and opportunities, coordinating regulatory agency interactions, reviewing scientific and clinical documentation, and ensuring compliance with applicable Food and Drug Administration (FDA), Department of War (DoW), Defense Health Agency (DHA), and international regulatory requirements. The position supports acquisition and product development efforts from concept development through product approval, fielding, and sustainment.

Duties and Responsibilities

The Contractor shall:

• Serve as the primary regulatory affairs advisor and subject matter expert for assigned medical product development and acquisition programs.
• Provide expert guidance regarding regulatory requirements 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 supporting product development, clinical development, regulatory submissions, and lifecycle management activities.
• Interpret and assess FDA regulations, guidance documents, directives, industry standards, and regulatory policies and communicate impacts to program stakeholders and leadership.
• Prepare, review, and support development of regulatory submissions and documentation, including but not limited to:
  • Investigational New Drug Applications (INDs)
  • New Drug Applications (NDAs)
  • Premarket Approval Applications (PMAs)
  • 510(k) submissions
  • Technical Files
  • Clinical Evaluation Reports
  • Regulatory meeting packages and minutes
  • Audit and inspection reports
  • Regulatory correspondence and responses to agency inquiries
• Coordinate and support interactions with FDA and other regulatory authorities, including meeting preparation, sponsor communications, response development, and management of regulatory commitments.
• Review and analyze scientific summaries, progress reports, clinical protocols, investigator brochures, safety reports, and surveillance data to ensure regulatory compliance and support product development decisions.
• Conduct regulatory gap analyses to evaluate processes, procedures, and documentation against applicable regulatory requirements and industry standards.
• Collaborate with multidisciplinary teams, including clinical, research and development, manufacturing, quality, acquisition, logistics, and operational stakeholders to ensure regulatory compliance throughout the product lifecycle.
• Assist in planning and execution of preclinical and clinical development programs and provide regulatory guidance regarding development milestones and submission requirements.
• Develop and maintain Integrated Master Plans (IMPs) and Integrated Master Schedules (IMSs) for regulatory and clinical development activities, including FDA and non-FDA milestones, deliverables, and timelines.
• Monitor evolving regulatory requirements and emerging industry trends and communicate their implications to program teams and leadership.
• Prepare and deliver briefings, technical assessments, decision papers, regulatory analyses, and recommendations for Government leadership and Integrated Product Teams.
• Provide training, mentoring, and technical guidance on regulatory requirements, best practices, and product development processes to Government personnel and program stakeholders.
• Advise Product Managers, IPTs, and senior leadership regarding regulatory risks, opportunities, compliance issues, and recommended mitigation strategies.
• Support portfolio-wide regulatory strategy development to optimize medical product development and acquisition efforts.

Minimum Qualifications

Education

Bachelor's degree in Regulatory Affairs, Biology, Chemistry, Biomedical Sciences, Pharmacy, Public Health, Engineering, or a related scientific discipline.

Experience

Minimum ten (10) years of progressively responsible experience supporting regulatory affairs activities for pharmaceutical, biologic, medical device, blood product, combination product, or other regulated healthcare product development programs.

Demonstrated experience in:

• Regulatory strategy development and implementation
• FDA regulatory pathways and submission processes
• Development and review of regulatory submissions
• Regulatory agency interactions and communications
• Clinical and nonclinical product development programs
• Product lifecycle management in regulated environments
• Multidisciplinary project team participation and leadership

Certification

Current and active Regulatory Affairs Certification (RAC) required.

Desired Qualifications

• 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.

Knowledge, Skills, and Abilities

The Contractor shall possess:

• Extensive knowledge of FDA regulatory requirements governing 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 effectively collaborating with cross-functional teams.
• Strong organizational and project management skills.
• Advanced proficiency using Microsoft Office 365 applications, including Word, Excel, PowerPoint, Teams, SharePoint, and Project.

Security Requirement

Must be eligible to obtain and maintain the personnel security requirements applicable to the contract and assigned duties.