Regulatory Project Manager I – GDUFA & FDA Research

Cognizance Technologies, LLC; Silver Spring (MD); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

PPO/HMO Health Plan (includes medical,

Job summary

Cognizance Technologies, LLC in Silver Spring, MD is seeking a Project Manager I to provide project and regulatory program support for GDUFA-related activities, including Pre-ANDA tasks and collaboration with interdisciplinary scientists.

The role emphasizes budgeting, tracking, archiving, and coordinating with internal and external stakeholders, with PMP certification or equivalent experience preferred, and familiarity with FDA programs.

Qualifications

• Experience coordinating research projects, timelines, and documentation across multiple stakeholders.
• Strong budgeting and financial management background with tracking against timelines and resource plans.
• Proficiency with Microsoft Office, SharePoint, and database systems; ability to learn Qdocs, Platform, and Nexus.
• Excellent written and verbal communication, including meeting minutes.
• Strong organizational skills to monitor multiple project timelines simultaneously.
• Ability to coordinate with internal and external collaborators.
• Hold a Project Management Professional (PMP) certification or equivalent experience.
• Experience supporting federal government program management or regulatory agency initiatives.
• Familiarity with FDA user fee programs or pharmaceutical regulatory processes preferred.
• Available to attend meetings and respond to FDA communications during core business hours.
• Demonstrated experience triaging, tracking, and archiving high volumes of work under short deadlines.

Responsibilities

• Triaging, tracking, and archiving high volumes of work projects.
• Provide project oversight, budgeting, and timeline management.
• Coordinate across internal and external stakeholders.
• Support development of product-specific guidance within OGDP.
• Assist in preparing documentation for regulatory reviews and decisions.
• Ensure continuity of regulatory review support aligned with GDUFA commitments.

Skills

Project coordination

Budget management

MS Office

SharePoint

Databases

Qdocs

Platform

Nexus

Clear communication

Stakeholder coordination

PMI-PMP certification

Federal government programs

FDA program familiarity

Meeting management

Budget tracking

Archiving

Tools

Qdocs

Platform

Nexus

Job description

Cognizance Technologies, LLC in Silver Spring, MD is seeking a Project Manager I to provide project and regulatory program support for GDUFA-related activities, including Pre-ANDA tasks and collaboration with interdisciplinary scientists.

The role emphasizes budgeting, tracking, archiving, and coordinating with internal and external stakeholders, with PMP certification or equivalent experience preferred, and familiarity with FDA programs.