PMTA Program Lead - Regulatory & Client Delivery

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan

Job summary

McKinney Regulatory Science Advisors is seeking a Project Manager, PMTA Programs to oversee FDA PMTA programs from planning through submission and post-submission activities. You will coordinate cross-functional teams across chemistry, toxicology, clinical and regulatory affairs to ensure on-time, on-budget delivery.

You will act as the primary client contact, manage budgets and schedules, and drive decisions with stakeholders.

Qualifications

• Bachelor's degree in any discipline.
• 5+ years of project or program management, with at least 3 years in a regulated product environment (tobacco, pharmaceutical, medical device, food or consumer product).
• Proven ownership of budgets, schedules and client relationships on concurrent engagements.
• Proficiency with MS Project, Smartsheet or equivalent scheduling tools, and Microsoft 365.
• Clear written and verbal communication with technical and executive audiences.
• Eligibility to handle Controlled Unclassified Information (CUI) and work in U.S. jurisdiction as required by client contracts.
• Demonstrated leadership of multidisciplinary teams without direct reporting authority, including difficult stakeholder conversations and conflict resolution.
• Experience managing integrated dependencies, evidence-based deliverable completion, and recovery of at-risk projects.

Responsibilities

• Lead program planning and delivery across PMTA projects.
• Coordinate cross-functional teams including chemistry, toxicology, clinical and regulatory affairs.
• Manage budgets, schedules, scope, and deliverables; track milestones and performance.
• Serve as primary client contact and lead meetings with documented decisions and owners.
• Ensure submission-readiness and coordination of regulatory submissions and responses.

Skills

Communication

Leadership

Client management

Education

Bachelor's degree

PMP/PgMP/RAC certification

Tools

MS Project

Smartsheet

Microsoft 365

Job description

McKinney Regulatory Science Advisors is seeking a Project Manager, PMTA Programs to oversee FDA PMTA programs from planning through submission and post-submission activities. You will coordinate cross-functional teams across chemistry, toxicology, clinical and regulatory affairs to ensure on-time, on-budget delivery.

You will act as the primary client contact, manage budgets and schedules, and drive decisions with stakeholders.