Senior Small Molecule Regulatory Affairs – Compliance Subject Matter Expert

Job not on LinkedIn

🔥 11 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

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Tunnell Consulting, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1962

🏛️ Government

🏥 Healthcare

💼 Consulting

Government • Healthcare • Consulting

Tunnell Consulting, Inc. is a government-focused consulting and services firm that provides scientific, technical, and project management expertise to federal agencies. The company’s offerings (branded as Tunnell Government Services) emphasize public health preparedness and response—helping defend the U. S. against major health threats—and scientific project portfolio management across all phases of R&D, including medical product development and portfolio oversight. They also provide staffing solutions to support government clients and transform organizations to meet agency missions.

📋 Description

• Provide strategic regulatory expertise, program management support, and technical guidance for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR®) initiative and related pharmaceutical manufacturing programs • Serve as the Federal Government's regulatory expert for FDA-regulated small-molecule drug products • Provide oversight and guidance regarding regulatory strategy, ANDA/NDA submissions, CMC development, manufacturing compliance, approval pathways, and lifecycle management • Serve as Regulatory Subject Matter Expert 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 • Monitor evolving FDA regulations, guidance documents, and industry expectations • Review and provide guidance on FDA submissions • Support data-driven submission strategies for efficient FDA review and approval • Evaluate submission readiness and regulatory documentation • Assess 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 regulatory representative on multidisciplinary teams supporting 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 discipline • 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 • Demonstrated experience leading or supporting successful FDA submissions and approvals, including ANDAs, DMFs, NDA supplements, and 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, and 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

🏖️ Benefits

• Employee-owned company • Approximately 20–25% travel • Equal employment opportunity consideration

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