Regulatory Project Manager – GDUFA/FDA Programs

Cognizant Technology Solutions Corporation; Silver Spring, Northern (MD, KY); Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

PPO/HMO Health Plan

Job summary

Cognizance Technologies, LLC is seeking a Full-time Project Manager I to support the Office of Generic Drug Policy on GDUFA-related programs in Silver Spring, MD. You will coordinate research tasks, manage budgets, and oversee documentation across stakeholders.

The role requires PMP or equivalent experience, strong IT skills, and familiarity with regulatory processes. This position emphasizes timely communication, cross-team collaboration, and meeting deadlines in a federal context.

Qualifications

• Experience coordinating research projects, timelines, and documentation across multiple stakeholders.
• Strong budgeting and financial management background.
• Proficiency with Microsoft Office, SharePoint, and database systems; ability to learn Qdocs, Platform, and Nexus.
• Excellent written and oral communication; meeting documentation and minute-taking.
• PMI PMP certification or equivalent.
• Experience supporting federal government program management or regulatory agency initiatives.
• Familiarity with FDA user fee programs or pharmaceutical regulatory processes is a plus.
• Availability to attend meetings and respond during core business hours.
• Experience triaging, tracking, and archiving high volumes of work projects under tight deadlines.

Responsibilities

• Triaging, budgeting, tracking, provide project oversight and archiving OGDP work projects.
• Support ongoing regulatory and research related tasks including Pre-ANDA program activities.
• Develop pertinent and useful research goals to support review processes and regulatory decision-making.
• Write and revise product-specific guidance documents; assist in achieving GDUFA program goals.
• Ensure continuity of OGDP's regulatory review support consistent with GDUFA/PDUFA commitments.

Skills

Project coordination

Budgeting

Communication

Organization

Stakeholder coordination

Education

PMP certification

Tools

Microsoft Office

SharePoint

Database systems

Qdocs

Platform

Nexus

Job description

Cognizance Technologies, LLC is seeking a Full-time Project Manager I to support the Office of Generic Drug Policy on GDUFA-related programs in Silver Spring, MD. You will coordinate research tasks, manage budgets, and oversee documentation across stakeholders.

The role requires PMP or equivalent experience, strong IT skills, and familiarity with regulatory processes. This position emphasizes timely communication, cross-team collaboration, and meeting deadlines in a federal context.