Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert
Bethesda, Maryland, United States · Remote OK
Senior+
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Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert
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Full-time
bachelor degree, postgraduate degree
Posted 46d ago
~40 hrs/week
Remote in United States
Responsibilities
Provide strategic regulatory expertise and technical guidance for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) initiative. Oversee FDA-regulated small-molecule drug products, focusing on submission strategies, CMC development, and manufacturing compliance.
Requirements
Requires a bachelor's degree in a scientific discipline and over 15 years of pharmaceutical industry experience in regulatory affairs or compliance. Must have a proven track record of successful FDA submissions and be a US Citizen or Green Card holder.
Full job description
Tunnell Government Services, Inc., is comprised of the industry’s leading scientists, medical and technical experts, and human capital and organizational development professionals. We approach all projects as a team and are committed to helping our clients transform and quickly achieve strategic goals. If you are interested in joining an employee-owned company that develops and implements innovative, integrated and differentiated solutions, please click on the links below to find the job that is right for you and contact us.
Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert
Location: 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 Overview
This 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.
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.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
Related keywords
Small MoleculeAPIFDACDERANDANDADMFCMCcGMPSAPIRGeneric MedicinesRegulatory ComplianceEmergency Use AuthorizationETPAMTPharmaceuticals
Tunnell Consulting, Inc., has served the pharmaceutical industry as scientific and technical consultants for over 50 years. In 2008, the Company established Tunnell Government Services, Inc. (TGS) as a wholly owned subsidiary to focus exclusively on government sector support. TGS currently provides support in the medical research and product development arena within the DoD (USAMRMC and Navy), HHS (BARDA and NIH), DHS (HQs S&T) and other federal agencies across the Public Health Emergency Management Countermeasures Enterprise (PHEMCE). Not just a source of laboratory research and support personnel, TGS brings established experience in practices that adhere to FDA guidelines and industrial acceptance. Our offerings include: Medical Product Development; CBRN and Emerging Infectious Disease Public Health Preparedness; Warfighter Protection; Biomedical IT; Healthcare and Medical Product Engineering/Technology; and Human Capital/Organizational Excellence. TGS provides a wide diversity of functional experts, from Ph.D level Immunologists, Biochemists, Molecular Biologists, Toxicologists, Physiologists and Veterinarians, etc. to research associate, research technician, research nurse, chemist, microbiologist, biologist, Principal Investigator and physiologist. With this background of work, relevant experience in both work and organizations, and robust recruitment capability, we feel confident that we can meet and exceed the challenges of our diversified customer portfolio.
Offices: 6701 Democracy Blvd., Bethesda, MD 20817, US
Integrated Scientific and Biomedical ServicesMedical Product Development including CountermeasuresPublic Health and Security related to CBRNEmerging Infectious DiseasesPandemic Influenzaand FDA and Clinical SupportBiotechnology
How many Healthcare jobs are open in Bethesda, MD right now?
There are currently 302 open healthcare positions in Bethesda, MD listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Bethesda, MD?
Companies currently hiring include Guidehouse, Tunnell Government Services, Inc., Sunrise Senior Living, Akicita Federal, Axle, among others. Browse the listings above to see every active employer.
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