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Small Molecule Drug Development Jobs in Washington

Granules

Manager, Analytical R&D

Chantilly, VA · On-site

$100K - $130K/yr

... drug release in tablet and capsule dosage form, orally disintegrating modified release tablets (XR ... Functional understanding of small molecule analytical development and associated regulatory and ...

Granules

Scientist III, Analytical R&D

Chantilly, VA · On-site

$85K - $95K/yr

Hands-on experience with drug substance and drug product analytical techniques such as HPLC, GC, KF ... Functional understanding of small molecule analytical development and associated regulatory and ...

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Small Molecule Drug Development information

What is small molecule drug development?

Small molecule drug development is the process of discovering, designing, and bringing to market pharmaceutical compounds that have low molecular weight and can easily enter cells to affect biological processes. These drugs are typically administered orally and are used to treat a wide range of diseases. The development process involves several stages, including target identification, compound screening, preclinical testing, and clinical trials before regulatory approval. Small molecule drugs are distinct from biologics, which are larger and more complex molecules like proteins or antibodies.

What are some common challenges faced by professionals in small molecule drug development, and how can they be addressed?

Professionals in small molecule drug development often face challenges such as balancing tight project timelines with rigorous regulatory requirements and managing cross-disciplinary collaboration between chemistry, biology, and clinical teams. Navigating unexpected results in preclinical or clinical studies can also require rapid problem-solving and adaptation. Building strong communication skills and staying updated on the latest regulatory guidelines and scientific advances can help address these challenges. Working closely with team members from diverse backgrounds fosters innovative solutions and keeps projects on track.

What are the key skills and qualifications needed to thrive in small molecule drug development, and why are they important?

To thrive in Small Molecule Drug Development, you need a strong background in chemistry, pharmacology, and molecular biology, typically supported by an advanced degree such as a Ph.D. or M.S. in a related field. Proficiency with laboratory techniques, analytical instrumentation (like HPLC and mass spectrometry), and drug discovery software is essential. Strong problem-solving skills, collaboration, and project management abilities help professionals excel in multidisciplinary teams. These skills and qualities are critical for efficiently advancing compounds through the drug discovery pipeline and ensuring compliance with regulatory standards.

What are popular job titles related to Small Molecule Drug Development jobs in Washington?

For Small Molecule Drug Development jobs in Washington, the most frequently searched job titles are:

What job categories do people searching Small Molecule Drug Development jobs in Washington look for?

The top searched job categories for Small Molecule Drug Development jobs in Washington are:

What cities in Washington are hiring for Small Molecule Drug Development jobs?

Cities in Washington with the most Small Molecule Drug Development job openings:

Small Molecule Drug Development jobs near you
Infographic showing various Small Molecule Drug Development job openings in Washington as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 18% Part Time, and 2% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution.

Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert

Tunnell Government Services

Bethesda, MD • Remote

Full-time

Re-posted 7 days ago

Job description

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.
  • 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.

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