Global Head of Technical Regulatory & Quality (CMC, Quality & MDD)
Core
Global oversight and leadership for Technical Regulatory, Chemistry, Manufacturing and Control (CMC), Quality, and Medical Device & Diagnostic (MDD) consulting services, including strategic planning for global dossiers and regulatory compliance.
Role type
Senior IC Global Head of Technical Regulatory & Quality
Builds
Global regulatory strategies, CMC content for dossiers, quality systems for medical devices and diagnostics, and client consulting solutions.
Domain
Healthcare / Clinical Research / Pharmaceutical & Medical Device Regulation
Deliverable
client delivery
Required skills
Expert understanding of scientific principles and regulatory technical CMC, Quality, and MDD requirements, Expert knowledge of regulatory Health Authorities and Notified Bodies review processes, Expertise in pharmaceutical drug and device development and global regulations, Advanced leadership skills including change management and strategic thinking, Ability to manage multiple complex projects, Risk assessment and mitigation strategies
Preferred skills
Experience in international Agency Interactions, Bid Defense and business development, Cross-functional team leadership
Technologies
None stated
Responsibilities
Sets vision and guides achievement of long-term organizational goals, Translates corporate strategy into long-range project plans, Oversees team services in CMC and MDD development and registration strategies, Interprets regulatory guidance for chemistry, pharmaceutical development, and manufacturing validation, Leads evaluation of new business opportunities and participates in Bid Defense meetings, Identifies and sponsors regulatory technical initiatives, Embeds continuous improvement strategies for operational execution, Manages and develops staff including professional development, Defines and tracks functional KPIs, Builds teams across functions and geographies, Anticipates and prioritizes risks to business and client goals
Seniority
Executive/Principal, Strategy & Mentorship