Senior Small Molecule Regulatory Affairs – Compliance Subject Matter Expert

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic regulatory guidance, program management assistance, and technical expertise for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR®) initiative and associated pharmaceutical manufacturing programs.

• Act as the Federal Government's regulatory authority on FDA-regulated small-molecule drug products.

• Oversee and advise on regulatory strategy, ANDA/NDA submissions, CMC development, manufacturing compliance, approval pathways, and lifecycle management.

• Function as the Regulatory Subject Matter Expert for small-molecule generic drug development, manufacturing, and approval programs.

• Offer scientific, technical, and regulatory guidance for designated programs and projects.

• Review and evaluate contractor and partner regulatory strategies, timelines, and submission plans.

• Facilitate and assess FDA interactions.

• Identify regulatory risks and propose mitigation strategies.

• Keep abreast of changing FDA regulations, guidance documents, and industry expectations.

• Review and provide insights on FDA submissions.

• Support data-driven submission strategies to ensure efficient FDA review and approval.

• Evaluate submission readiness and regulatory documentation.

• Analyze CMC strategies for API and drug product programs.

• Review manufacturing development plans, technology transfer strategies, validation programs, and readiness for commercial manufacturing.

• Conduct regulatory research, gather intelligence, and assess the competitive landscape.

• Monitor trends in generic drug approvals, manufacturing regulations, and initiatives for supply chain resilience.

• Serve as the regulatory representative on multidisciplinary teams that support strategic pharmaceutical manufacturing initiatives.

• Collaborate with Government leadership, pharmaceutical manufacturers, CDMOs, regulatory agencies, quality organizations, and technical teams.

⛳️ Requirements

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, Biology, Regulatory Affairs, or a related scientific field.

• 15+ years of experience in the pharmaceutical industry, focusing on small-molecule drug development, manufacturing, regulatory affairs, quality, or compliance functions.

• Experience in supporting and implementing regulatory emergency response mechanisms, including Emergency Use Authorization (EUA), expiration dating extensions, and enforcement discretion strategies.

• Familiarity with FDA Emerging Technology Program (ETP) engagements and Advanced Manufacturing Technology (AMT) initiatives.

• Proven track record of leading or assisting with successful FDA submissions and approvals, including ANDAs, DMFs, NDA supplements, and post-approval changes.

• Extensive experience in direct interactions with the FDA, 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, and Quality Systems.

• Experience in supporting manufacturing operations, technology transfer, validation, and commercial production activities.

• Ability to evaluate complex regulatory, manufacturing, and compliance issues and devise practical solutions.

• Excellent written and verbal communication skills.

• Must be a US Citizen or a Full Green Card holder.

🏝️ Benefits

• Employee-owned company.

• Approximately 20–25% travel.

• Equal employment opportunity consideration.