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Fda Project Jobs (NOW HIRING)

Cayuga Milk Ingredients

Senior Process Engineer

Auburn, NY · On-site

$125K - $179K/yr

Ensure compliance with FDA, PMO, SQF, OSHA, environmental regulations, and company standards. Technical Leadership * Serve as a key technical resource for Operations, Maintenance, Quality, and ...

DRT Strategies

Technical Writer - FDA

Silver Spring, MD · On-site

They are seeking a Technical Writer to support the FDA's Center for Drug Evaluation and Research by ... DRT Strategies is a management consulting company that offers information technology, project ...

LabAnswer

LIMS SME/Business Analyst

Atlanta, GA · Remote

Work with end users and management to analyze and document user needs Participate in and facilitate meetings, Work with the project team and FDA leadership to identify data needs for LIMS and/or ELN ...

Alston

FDA Technical Consultant

Washington, DC · On-site +1

Perform special projects as assigned SKILLS NEEDED TO BE SUCCESSFUL * Regular travel within the ... FDA experience required. * Minimum of 5 years as an FDA investigator or compliance officer, or ...

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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 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 are the key skills and qualifications needed to thrive as an FDA Project Manager, and why are they important?

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.
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Fda Project jobs near you
Infographic showing various Fda Project job openings in the United States as of June 2026, with employment types broken down into 88% Full Time, 9% Part Time, and 3% Contract. Highlights an 86% Physical, 4% Hybrid, and 10% Remote job distribution.
Senior Project Manager (FDA Background)

Senior Project Manager (FDA Background)

Oran Inc

Washington, DC

Full-time

Posted 12 days ago

Job description

Position Overview

We are seeking an experienced Senior Project Manager with a strong FDA background and experience leading Artificial Intelligence (AI) initiatives within regulated environments. The ideal candidate will manage complex projects across FDA programs, ensuring compliance with regulatory requirements while driving innovation through AI, automation, data analytics, and digital transformation solutions.

Key Responsibilities

  • Lead the planning, execution, and delivery of FDA-regulated projects and programs.
  • Manage cross-functional teams, stakeholders, vendors, and technical resources.
  • Oversee project schedules, budgets, risks, and performance metrics.
  • Ensure compliance with FDA regulations, policies, and quality standards.
  • Drive AI and digital transformation initiatives, including Generative AI, machine learning, automation, and advanced analytics solutions.
  • Collaborate with business and technical teams to identify opportunities for AI-enabled process improvements and operational efficiencies.
  • Develop project plans, governance frameworks, status reports, and executive briefings.
  • Support change management, user adoption, and stakeholder engagement activities.
  • Maintain audit-ready project documentation and ensure adherence to regulatory and organizational requirements.

Required Qualifications

  • Bachelor's degree in Business, Information Technology, Life Sciences, Engineering, Public Health, or a related field.
  • 8+ years of project or program management experience.
  • Experience supporting FDA organizations, FDA-regulated industries, or federal health programs.
  • Demonstrated experience managing AI, Generative AI, machine learning, automation, or data-driven transformation projects.
  • Strong understanding of FDA regulatory processes and compliance requirements.
  • Experience leading cross-functional teams in complex, highly regulated environments.
  • Excellent communication, leadership, organizational, and stakeholder management skills.

Preferred Qualifications

  • PMP, PgMP, Agile, Scrum, or equivalent certification.
  • Experience supporting FDA Centers or Programs such as CDER, CBER, CDRH, ORA, HFP, OCE, or related organizations.
  • Familiarity with AI governance, responsible AI practices, data management, and emerging technologies.
  • Experience with cloud platforms, analytics tools, or enterprise digital transformation initiatives.