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Remote Fda Pharmacist Jobs (NOW HIRING)

LabAnswer

LIMS SME/Business Analyst

Atlanta, GA · Remote

LabAnswer performs significant laboratory automation work in pharmaceuticals, bio-pharmaceuticals ... This is a remote position so the candidate can live anywhere in the USA. The position will require ...

Boutique Recruiting

Remote General Manager

Boulder, CO · On-site +1

$200K - $230K/yr

... or pharmaceutical industry * Extensive experience in the U.S. healthcare market, including sales ... Strong understanding of FDA and U.S. payer systems * Experience engaging with Boards of Directors ...

Vue Health

Digital Designer-Freelance/Hourly

Boston, MA · Remote

$65/hr

Freelance Digital Designer (Pharmaceutical Advertising) - 100% Remote We're looking for a Freelance ... Ensure all work aligns with FDA/regulatory guidelines and client brand standards * Manage multiple ...

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Remote Fda Pharmacist information

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How much do remote fda pharmacist jobs pay per hour?

As of Aug 11, 2026, the average hourly pay for remote fda pharmacist in the United States is $60.91, according to ZipRecruiter salary data. Most workers in this role earn between $56.01 and $67.31 per hour, depending on experience, location, and employer.

What is the difference between Remote Fda Pharmacist vs Remote Pharmacy Technician?

AspectRemote Fda PharmacistRemote Pharmacy Technician
CredentialsDoctor of Pharmacy (PharmD), licensure, FDA knowledgeCertification (CPhT), state registration, pharmacy tech training
Work EnvironmentRegulatory agencies, pharmaceutical companies, remote reviewPharmacy settings, medication dispensing, inventory management
Employer & IndustryFDA, pharmaceutical firms, healthcare complianceRetail, hospital, mail-order pharmacies
Search & Comparison IntentUnderstanding regulatory roles, FDA complianceMedication processing, pharmacy support tasks

Remote Fda Pharmacists focus on regulatory compliance, drug safety, and FDA guidelines, requiring advanced pharmacy credentials. Remote Pharmacy Technicians assist with medication dispensing and inventory, typically needing certification but less advanced education. Both roles are remote but serve different functions within the healthcare and pharmaceutical industries.

More about Remote Fda Pharmacist jobs
What cities are hiring for Remote Fda Pharmacist jobs? Cities with the most Remote Fda Pharmacist job openings:
What are the most commonly searched types of Fda Pharmacist jobs? The most popular types of Fda Pharmacist jobs are:
What states have the most Remote Fda Pharmacist jobs? States with the most job openings for Remote Fda Pharmacist jobs include:
What job categories do people searching Remote Fda Pharmacist jobs look for? The top searched job categories for Remote Fda Pharmacist jobs are:
Remote Fda Pharmacist jobs near you
Infographic showing various Remote Fda Pharmacist job openings in the United States as of August 2026, with employment types broken down into 2% Internship, 2% As Needed, 71% Full Time, 23% Part Time, and 2% Contract. Highlights an 99% Physical, and 1% Remote job distribution, with an average salary of $126,701 per year, or $60.9 per hour.

Senior Small Molecule Regulatory Affairs & Compliance Subject Matter Expert

Tunnell Government Services

Washington, DC • Remote

Full-time

Posted 12 days ago

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.
  • 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.

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.