Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert

Position Overview

The Senior Small Molecule Regulatory Affairs & Compliance SME will provide strategic regulatory expertise, program management support, and technical guidance for the SAPIR® initiative and related pharmaceutical manufacturing programs.

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.
• Ability to assess complex regulatory, manufacturing, and compliance issues and develop practical solutions.
• Strong written and verbal communication skills.