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Remote Fda Contract Jobs in Silver Spring, MD (NOW HIRING)

Hirekeyz Inc

Scientist II

College Park, MD · Remote

... Remote but need to report to the duty station in college park, MD or other FDA facilities within DC metropolitan area as per need) : So, look for local candidates. Duration: Long Term Contract

The Emmes Company, LLC

Medical Officer

Rockville, MD · Remote

Overview Medical Officer US Remote Emmes Group: Building a better future for us all. Emmes Group is ... Reviews the FDA MedWatch Alerts, safety communications and or other communications from other ...

Emmes

Medical Officer

Rockville, MD · Remote

Overview Medical Officer US Remote Emmes Group: Building a better future for us all. Emmes Group is ... Reviews the FDA MedWatch Alerts, safety communications and or other communications from other ...

The Emmes Company, LLC

Medical Officer

Rockville, MD · Remote

Overview Medical Officer US Remote Emmes Group: Building a better future for us all. Emmes Group is ... Reviews the FDA MedWatch Alerts, safety communications and or other communications from other ...

TRI Challenge Convention

Central Monitor

Bethesda, MD · Remote

$18.25 - $19.50/hr

Applies a thorough understanding of regulatory (FDA requirements, GCPs/ICH guidelines), data ... contract, is a plus. This role is fully remote to those in/willing to relocate to Maryland ...

BryceTech

Regulatory Data Technical Advisor

Washington, DC · Remote

$131K - $131K/yr

With a proven track record of winning sought-after contracts, scaling high-performance teams, and ... hybrid/remote work environment Preferred Qualifications: * Extensive knowledge of FDA/ICH ...

BryceTech

Regulatory Data Technical Advisor

Washington, DC · On-site +1

$131K - $131K/yr

With a proven track record of winning sought-after contracts, scaling high-performance teams, and ... hybrid/remote work environment Preferred Qualifications: * Extensive knowledge of FDA/ICH ...

BryceTech

Regulatory Data Technical Advisor

Washington, DC · Remote

$131K - $131K/yr

With a proven track record of winning sought-after contracts, scaling high-performance teams, and ... hybrid/remote work environment Preferred Qualifications: * Extensive knowledge of FDA/ICH ...

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Remote Fda Contract information

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How much do remote fda contract jobs pay per hour?

As of Jun 15, 2026, the average hourly pay for remote fda contract in Silver Spring, MD is $39.38, according to ZipRecruiter salary data. Most workers in this role earn between $24.62 and $46.73 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Remote FDA Contract Specialist, and why are they important?

To thrive as a Remote FDA Contract Specialist, you need expertise in contract management, regulatory compliance, and a solid understanding of FDA procedures, often supported by a degree in law, business, or a related field. Familiarity with contract management software, federal acquisition systems, and relevant certifications like CFCM (Certified Federal Contracts Manager) is typically required. Exceptional attention to detail, strong negotiation skills, and effective communication are crucial soft skills for this role. These competencies ensure accurate, compliant contract execution and foster strong working relationships with stakeholders while meeting federal regulations.

What is the difference between Remote Fda Contract vs Remote Fda Investigator?

AspectRemote Fda ContractRemote Fda Investigator
CredentialsTypically requires a background in regulatory affairs, life sciences, or related fields; may need FDA-specific certificationsRequires a background in clinical research, regulatory science, or life sciences; often needs FDA investigator certification or related credentials
Work EnvironmentContract-based, remote or onsite depending on project; project-specific rolesPrimarily remote or onsite inspections, audits, and investigations for FDA compliance
Employer & Industry UsageUsed by pharmaceutical, biotech, and medical device companies for regulatory compliance projectsUsed by FDA and contract agencies for conducting inspections and investigations

Remote Fda Contract roles focus on regulatory projects and compliance consulting, often contract-based and project-specific. Remote Fda Investigators conduct inspections and investigations to ensure FDA compliance, often requiring specific certifications. Both roles are vital in the regulatory landscape but differ in responsibilities and work settings.

What are some common challenges faced when working in a remote FDA contract role, and how can they be managed?

Remote FDA contract roles often involve navigating complex regulatory requirements while collaborating with cross-functional teams in a virtual environment. One common challenge is effective communication, as remote work can sometimes lead to misunderstandings or delays in feedback. To manage this, it's important to establish clear communication channels and regular check-ins with team members. Additionally, staying updated with evolving FDA guidelines and maintaining organized documentation are critical for compliance and project success. Leveraging project management tools and fostering a proactive, detail-oriented mindset can help ensure deliverables meet regulatory standards and deadlines.

What is a Remote FDA Contract?

A Remote FDA Contract refers to a job or project agreement where an individual or company provides services to the U.S. Food and Drug Administration (FDA) or related organizations from a remote location, rather than working onsite. These contracts often involve regulatory consulting, compliance documentation, project management, or data analysis to help clients meet FDA requirements. Remote FDA contractors may work independently or as part of a remote team, and they are expected to stay updated on FDA regulations and guidance. This role offers flexibility in location and hours but requires strong communication skills and a thorough understanding of FDA standards.
What are popular job titles related to Remote Fda Contract jobs in Silver Spring, MD? For Remote Fda Contract jobs in Silver Spring, MD, the most frequently searched job titles are:
What job categories do people searching Remote Fda Contract jobs in Silver Spring, MD look for? The top searched job categories for Remote Fda Contract jobs in Silver Spring, MD are:
What cities near Silver Spring, MD are hiring for Remote Fda Contract jobs? Cities near Silver Spring, MD with the most Remote Fda Contract job openings:
Remote Fda Contract jobs near you
Regulatory Affairs Supervisor- REMOTE

Regulatory Affairs Supervisor- REMOTE

i4 Search Group Healthcare

Baltimore, MD • Remote

$80K - $100K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 4 days ago

Job description

Job Description: Regulatory Affairs Supervisor (Clinical Trials)

Position Title: Regulatory Affairs Supervisor

Location: Remote (U.S.-Based) - Any Location

Employment Type: Full-Time


Position Summary

We are seeking an experienced and detail-oriented Regulatory Affairs Supervisor to lead regulatory operations supporting clinical research activities. This role will oversee a team of Clinical Research Coordinators (CRCs) and regulatory staff while ensuring compliance with federal regulations, sponsor requirements, institutional policies, and Good Clinical Practice (GCP) guidelines.

The Regulatory Affairs Supervisor will serve as a key liaison between investigators, sponsors, contract research organizations (CROs), and regulatory agencies to support the successful execution of clinical trials from study startup through closeout.


Key Responsibilities

Regulatory Leadership & Oversight

  • Supervise and mentor regulatory coordinators and Clinical Research Coordinators (CRCs).
  • Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional policies.
  • Oversee preparation, submission, and maintenance of regulatory documents for clinical trials.
  • Manage regulatory activities throughout the study lifecycle, including startup, amendments, continuing reviews, reportable events, and study closeout.
  • Maintain regulatory binders, essential documents, and study files to ensure audit readiness.


Clinical Trial Management Support

  • Collaborate with Principal Investigators, study teams, sponsors, and CROs to facilitate regulatory compliance and study execution.
  • Review study protocols, informed consent documents, investigator brochures, and sponsor communications.
  • Support site initiation, monitoring, audit, and closeout activities.
  • Track regulatory milestones and ensure timely submissions and approvals.


Team Supervision

  • Provide leadership, training, onboarding, and performance management for CRCs and regulatory personnel.
  • Establish workload priorities and ensure timely completion of regulatory deliverables.
  • Develop standard operating procedures (SOPs) and best practices to improve operational efficiency.
  • Foster a culture of quality, accountability, and continuous improvement.


Quality & Compliance

  • Conduct internal audits and quality reviews of study documentation.
  • Identify compliance risks and implement corrective and preventive actions (CAPAs).
  • Serve as a regulatory subject matter expert during sponsor audits, FDA inspections, and institutional reviews.
  • Monitor regulatory changes and communicate updates to research staff.


Required Qualifications

  • Bachelor's degree in Life Sciences, Healthcare Administration, Public Health, Nursing, Pharmacy, or related field.
  • 5+ years of experience supporting clinical research and regulatory affairs.
  • 2+ years of supervisory or team leadership experience.
  • Strong knowledge of:
  • FDA regulations
  • ICH-GCP guidelines
  • Human Subjects Protection requirements
  • IRB processes
  • Clinical trial operations
  • Experience managing regulatory submissions for multiple clinical studies.
  • Excellent organizational, communication, and project management skills.


Preferred Qualifications

  • Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent certification.
  • Experience with oncology, device, pharmaceutical, or multisite clinical trials.
  • Familiarity with CTMS, eRegulatory systems, and electronic document management platforms.
  • Experience supporting FDA inspections and sponsor audits.


Benefits

  • Fully remote work environment
  • Competitive salary
  • Medical, dental, and vision insurance
  • Paid time off and holidays
  • 401(k) with company match
  • Professional development opportunities
  • Career growth within a collaborative research organization


Ideal Candidate:

The ideal candidate is a proactive regulatory professional with strong clinical research experience who enjoys leading teams, ensuring compliance, and supporting high-quality clinical trial execution in a fast-paced remote environment.