Senior Small Molecule Regulatory Affairs & Compliance Subject Matter ExpertLocation: Remote (U.S.-based) with approximately 20-25% travel
The Senior Small Molecule Regulatory Affairs & Compliance SME will provide strategic regulatory expertise, program management support, and technical guidance for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR®) initiative and related pharmaceutical manufacturing programs. This initiative seeks to establish a resilient domestic ecosystem for the development, approval, manufacturing, stockpiling, and deployment of critical small-molecule generic medicines and their active pharmaceutical ingredients (APIs).
The selected individual will serve as the Federal Government's regulatory expert for FDA-regulated small-molecule drug products, providing oversight and guidance regarding regulatory strategy, ANDA/NDA submissions, CMC development, manufacturing compliance, approval pathways, and lifecycle management activities.
Position OverviewThis position serves as a senior regulatory affairs and compliance SME supporting programs involving:
- Small molecule APIs and finished dosage forms
- Generic drug development and approval
- Strategic API stockpiling initiatives
- Domestic manufacturing expansion and reshoring efforts
- Manufacturing technology modernization
- Supply chain resiliency and emergency preparedness programs
- FDA regulatory engagement and product approval activities
The candidate will work closely with Government leadership, pharmaceutical manufacturers, CDMOs, regulatory agencies, quality organizations, and technical teams to ensure products and manufacturing operations meet regulatory requirements and support program objectives.
Key Responsibilities- Serve as Regulatory Subject Matter Expert (SME) for small-molecule generic drug development, manufacturing, and approval programs.
- Provide scientific, technical, and regulatory guidance for assigned programs and projects.
- Review and assess contractor and partner regulatory strategies, timelines, and submission plans.
- Support and evaluate FDA interactions
- Assess regulatory risks and recommend mitigation strategies to support successful approvals and compliance objectives.
- Monitor evolving FDA regulations, guidance documents, and industry expectations relevant to generic pharmaceuticals.
- Review and provide guidance on FDA submissions.
- Support development of data-driven submission strategies that facilitate efficient FDA review and approval.
- Evaluate submission readiness and regulatory documentation supporting approvals of critical generic medicines.
- Assess Chemistry, Manufacturing, and Controls (CMC) strategies for API and drug product programs.
- Review manufacturing development plans, technology transfer strategies, validation programs, and commercial manufacturing readiness.
- Conduct regulatory research, intelligence gathering, and competitive landscape assessments.
- Monitor trends in generic drug approvals, manufacturing regulations, and supply chain resiliency initiatives.
- Serve as the regulatory representative on multidisciplinary teams supporting strategic pharmaceutical manufacturing initiatives.
Required Qualifications- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, Biology, Regulatory Affairs, or a related scientific discipline.
- Advanced degree (M.S., Pharm.D., MBA, J.D., Ph.D., or equivalent) strongly preferred.
- 15+ years of pharmaceutical industry experience supporting small-molecule drug development, manufacturing, regulatory affairs, quality, or compliance functions.
- Experience supporting and implementing regulatory emergency response mechanisms, including Emergency Use Authorization (EUA), expiration dating extensions, and enforcement discretion strategies.
- Experience with FDA Emerging Technology Program (ETP) engagements and Advanced Manufacturing Technology (AMT) initiatives, including the evaluation, implementation, and regulatory support of innovative manufacturing processes and platforms.
- Demonstrated experience leading or supporting successful FDA submissions and approvals, including:
- ANDAs
- DMFs
- NDA supplements
- Post-approval changes
- Extensive experience interacting directly with FDA and supporting regulatory meetings and inspections.
- Strong knowledge of:
- FDA drug approval pathways
- Generic drug regulations
- CDER review processes
- cGMP requirements
- CMC regulatory requirements
- Drug Master Files
- Quality Systems
- Experience supporting manufacturing operations, technology transfer, validation, and commercial production activities.
- Ability to assess complex regulatory, manufacturing, and compliance issues and develop practical solutions.
- Strong written and verbal communication skills.
Must be a US Citizen or a Full Green Card holder.
