Improver

Pat Mann

Senior Director Technical and Regulatory Consulting at PPD

Greater Philadelphia

Adaptable, strategic leader and collaborative team member who is able to fully utilize resources and shift focus in response to a dynamic business environment, to overcome obstacles to successfully deliver a consistently high level of quality work product and operational excellence.

Skilled regulatory negotiator with strong drug, device and biologic foundational experience and understanding of clinical, chemistry, manufacturing and controls strategy and compliance requirements necessary to obtain global Board of Health approvals for clinical trial applications, marketing authorizations and lifecycle variations.

Consistently identifies and drives process improvements, able to handle multiple complex priorities and collaboratively work across the organization horizontally or vertically in different business units to achieve or exceed business objectives. Proactively anticipates issues and takes appropriate action for resolution. Experienced people leader committed to talent development.

Specialties: Business and technical process integration and optimization. Skilled negotiator. Regulatory CMC expert. Six Sigma Greenbelt.

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Experience:

• Senior Director Regulatory Affairs (Wyeth Research)
• Director CMC Global Regulatory Affairs (PPD)
• Senior Director Worldwide Regulatory Strategy Established Products (Pfizer)
• Quality Assurance Microbiology Supervisor (Terumo Medical Elkton, MD)
• Quality Assurance Microbiologist (Carlisle Laboratories, Inc Inwood NY)
• Senior Director Technical and Regulatory Consulting (PPD)

Skills: