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Fda Project Jobs (NOW HIRING)

NeevSys Inc

Help Desk Manager

Rockville, MD · On-site

Coordinate Tier 3 support with FDA project teams, application owners, infrastructure teams, vendors, and technical specialists. * Maintain ownership and customer communication through issue ...

New

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 ...

GDIT

Program Delivery Manager - FDA

Falls Church, VA · Hybrid

$157K - $212K/yr

Project Management Professional (PMP) | Project Management Institute (PMI) - Project Management ... This role is hybrid, requiring 3 days in office at the GDIT Gaithersburg office and FDA Silver ...

GDIT

Program Delivery Manager - FDA

Gaithersburg, MD · Hybrid

$157K - $212K/yr

Project Management Professional (PMP) | Project Management Institute (PMI) - Project Management ... This role is hybrid, requiring 3 days in office at the GDIT Gaithersburg office and FDA Silver ...

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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 July 2026, with employment types broken down into 80% Full Time, 17% Part Time, 2% Contract, and 1% Nights. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution.

Senior Director, Clinical Pharmacology

Revolution Medicines

Redwood City, CA • Hybrid

Other

Re-posted 16 days ago

Job description

The Opportunity:

We are seeking a passionate and experienced Clinical Pharmacologist with strong early development background to be part of the Nonclinical Development and Clinical Pharmacology (NDCP) Organization.

  • As a member of the Early Development Clinical Pharmacology group, you will:

  • Provide strategic insight and technical leadership within the Clinical Pharmacology function.

  • Author technical reports and/or regulatory documents for major milestones of clinical development, specifically IND, EOP1 & EOP2 Briefing Documents. Participate in regulatory interactions and responses to regulatory questions.

  • Apply state-of-the-art quantitative modeling, including translational PK/PD, population PK, and exposure-response analyses, to guide recommended phase 2 dose/schedule (RP2Ds) selection for pivotal studies.

  • Work with the Discovery organization to support assets in the IND-enabling stage, including collaboration with DMPK and Toxicology groups in assessment of human start dose and assessment of the need for human DDI studies.

  • Work with the Clinical Development team in designing FIH study.

  • Design and report Clin Pharm studies such as hADME, Food-Effect and DDI studies.

  • Engage and work with CROs on clinical pharmacology activities.

  • Represent the Clinical Pharmacology function in project teams and build strong working relationships with cross-functional teams to impact critical decisions.

Required Skills, Experience and Education:

  • A Ph.D. or Pharm.D (with Fellowship) with Pharmaceutical Sciences background with 8+ years of relevant industry experience in Clinical Pharmacology.

  • Prior experience with small molecules oncology drug development.

  • Familiar with FDA's Project Optimus guidance.

  • Well-informed in current and emerging standards of regulatory requirements and expectations for clinical pharmacology.

  • Hands-on experience with WinNonlin and Clin Pharm study designs.

  • Strong understanding of DMPK, CMC and Toxicology and related regulatory guidance is required.

  • Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.

  • A critical thinker and passionate team player and quick learner with high energy who thrives in a dynamic and fast-paced environment.

  • Prior management experience.

Preferred Skills:

  • Prior experience interacting with FDA on dose optimization.

  • Hand-on experience with PBPK models.

#LI-Hybrid #LI-CT1

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