PMTA Program Manager – Regulatory & Cross-Functional Lead

McKinney Regulatory Science Advisors (RSA); Richmond (VA); On-site; USD 105,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Job summary

McKinney Regulatory Science Advisors is seeking a Project Manager to lead PMTA programs from planning through FDA submission and post-submission activities. You will coordinate cross-functional teams to ensure on-time, on-budget delivery.

This on-site Virginia role requires 5+ years in project management within a regulated environment, strong client leadership, and proficiency with MS Project, Smartsheet and Microsoft 365. We offer competitive compensation and a comprehensive benefits package.

Qualifications

• Bachelor's degree in any discipline.
• 5+ years of project or program management in a regulated product environment.
• Experience managing budgets, timelines and client relationships.
• Proficiency with MS Project, Smartsheet or equivalent scheduling tools.
• Clear written and verbal communication for technical and executive audiences.
• Eligibility to work in U.S. jurisdiction.

Responsibilities

• Build and maintain the integrated master schedule for the program.
• Coordinate submission assembly and responses to deficiency letters.
• Lead Work Stream Owners and coordinate cross-functional teams.
• Monitor budgets, forecasts and invoicing milestones.
• Provide concise executive updates on risks and decisions.

Skills

Project management

Regulatory program management

Cross-functional coordination

Client relationship management

MS Project / Smartsheet

Communication

Education

Bachelor's degree

Tools

MS Project

Smartsheet

Microsoft 365

Job description

McKinney Regulatory Science Advisors is seeking a Project Manager to lead PMTA programs from planning through FDA submission and post-submission activities. You will coordinate cross-functional teams to ensure on-time, on-budget delivery.

This on-site Virginia role requires 5+ years in project management within a regulated environment, strong client leadership, and proficiency with MS Project, Smartsheet and Microsoft 365. We offer competitive compensation and a comprehensive benefits package.