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Fda Project Jobs in Washington, DC (NOW HIRING)

Brillient

Project Manager

Landover, MD · On-site

Serve as a contract project manager for a FDA records management program. This role will: * Direct and oversee the performance of operations personnel involved in records management, document ...

Apex Systems

FDA Systems Engineer I

Ashburn, VA · On-site

Experience coordinating or supporting infrastructure projects, including hardware refreshes, migrations, and deployments. * Knowledge of data center standards, power infrastructure, change management ...

Cni

Project Manager III

Silver Spring, MD · On-site

$100K - $135K/yr

The Project Manager III manages, plans and coordinates the full life-cycle of projects for the U ... S. Food and Drug Administration (FDA), specifically for the Office of Food Policy and Response ...

GDIT

Program Manager

Gaithersburg, MD · Hybrid

$176K - $239K/yr

No Seize your opportunity to make a personal impact as a Program Manager supporting FDA activities.GDIT is your place to make meaningful contributions to challenging projects, build your skills, and ...

GDIT

Program Manager

College Park, MD · Hybrid

$176K - $239K/yr

No Seize your opportunity to make a personal impact as a Program Manager supporting FDA activities.GDIT is your place to make meaningful contributions to challenging projects, build your skills, and ...

CAMRIS

GMP Senior Project Manager

Silver Spring, MD · On-site

Knowledge of GMP, EU, FDA, ISPE guidance as it applies to multi-modal pharmaceutical manufacturing ... Capital project management experience.SmartSheet experience.Leadership experience.Physical ...

CAMRIS

GMP Senior Project Manager

Silver Spring, MD · On-site

$128K - $147K/yr

Knowledge of GMP, EU, FDA, ISPE guidance as it applies to multi-modal pharmaceutical manufacturing ... CDMO project management experience. * Capital project management experience. * SmartSheet ...

Hirekeyz Inc

Scientist II

College Park, MD · Remote

... FDA facilities within DC metropolitan area as per need) : So, look for local candidates. Duration: Long Term Contract * Implements scientific project. * Develops requirements from a project ...

ICF

Project Manager / PMO Lead - Hybrid

Washington, DC · Hybrid

ICF is seeking an experienced Project Manager / PMO Lead to support delivery of a complex federal ... Experience with federal IT programs in HHS, NIH, FDA, CMS, CDC, or other health-focused agencies

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All JobsFda Project JobsFda Project Jobs in Washington, DC

Fda Project information

What is an FDA project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What are the key skills and qualifications needed to thrive as an FDA project manager?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What qualifications do you need to work for the FDA?

To work as an FDA project professional, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or health sciences. Advanced positions may require a master's degree or higher, along with relevant experience, knowledge of regulatory guidelines, and strong analytical skills. Certifications like Regulatory Affairs Certification (RAC) can also enhance qualifications.
Fda Project jobs near you
Infographic showing various Fda Project job openings in Washington, DC as of August 2026, with employment types broken down into 87% Full Time, 8% Part Time, and 5% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution.

Project Manager

LifeSciences Regulatory Solutions, LLC

Columbia, MD • Remote

Full-time

Medical, Dental, Retirement, PTO

Posted 21 days ago

Job description

Benefits:
  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Home office stipend
  • Paid time off


Job Purpose:
Leading strategic and operational initiatives as a key partner to the drug and medical device operational teams. Assisting with driving projects forward, identifying new business opportunities from within existing clients, mitigating risks, and driving alignment across departments while ensuring projects are delivered on time, within scope, and budget. 

Duties:
  • Develop and maintain integrated project plans, timelines, milestones, budgets, resource requirements, project dashboards, and success metrics.
  • Lead and manage cross-functional drug and medical device development projects from discovery through commercialization, ensuring alignment with client and organizational objectives.
  • Coordinate and facilitate collaboration among scientific, clinical, regulatory, quality, operational, and business stakeholders to ensure successful project execution.
  • Monitor project progress, identify risks, dependencies, and bottlenecks, and implement mitigation strategies to maintain project timelines and deliverables.
  • Serve as the primary point of contact for clients and internal stakeholders, providing regular project updates, recommendations, and executive-level reporting.
  • Manage multiple projects simultaneously, ensuring deliverables are completed on time, within scope, within budget, and in compliance with quality and regulatory requirements.
  • Support clinical and product development activities, including study planning, regulatory submissions and meetings, and commercialization readiness.
  • Prepare and present project reports, dashboards, and strategic recommendations to clients, leadership, and cross-functional teams.
  • Monitor project expenditures and resource utilization, identify budget variances, and recommend corrective actions as needed.
  • Identify opportunities for additional services, business growth, and process enhancements within existing client programs.
  • Build and maintain strong relationships with clients, external partners, and internal stakeholders to support long-term project and business success.
  • Contribute to strategic planning, organizational initiatives, proposal development, and other special projects as assigned.

Skills/Qualifications:

  • Bachelor's degree in Life Sciences, Biotechnology, Engineering, Business, Project Management, or a related field; advanced degree (MS, MBA, PharmD, or equivalent) preferred.
  • 5+ years of project management experience within pharmaceutical, biotechnology, medical device, diagnostics, CRO, CDMO, or other regulated life sciences environments.
  • Demonstrated knowledge of drug and/or medical device development processes, including product development, clinical research, regulatory submissions, quality systems, and commercialization activities.
  • Strong project management expertise, including planning, scheduling, budgeting, resource management, risk assessment, and execution of complex cross-functional projects.
  • Proven ability to manage multiple priorities simultaneously while delivering projects on time, within scope, and within budget.
  • Strong analytical, problem-solving, and critical-thinking skills with the ability to translate complex information into actionable recommendations.
  • Excellent verbal, written, presentation, and interpersonal communication skills, with the ability to effectively engage clients, executives, scientists, clinicians, and regulatory professionals.
  • Knowledge of applicable regulatory requirements and industry standards, including FDA regulations, GCP, GMP, GLP, ISO standards, and other relevant compliance frameworks.
  • Experience utilizing project management tools and business software, including SmartSheet, Microsoft Project, and advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word, Outlook).
  • Strong organizational, time management, and executive functioning skills with the ability to work independently and manage competing deadlines.
  • Customer-focused mindset with a commitment to quality, operational excellence, continuous improvement, and exceptional service delivery.

 

This is a remote position.