Global Head of Technical Regulatory & Quality (CMC, Quality & MDD)
Core
Provides global oversight and leadership for Chemistry, Manufacturing and Control (CMC), Quality, and Medical Device & Diagnostic (MDD) consulting services, including strategic planning for global dossiers, QA unit support, and quality system development.
Role type
Senior leadership (Global Head) in Technical Regulatory & Quality
Builds
Global regulatory strategy and quality systems for pharmaceutical and medical device clients
Domain
Healthcare / Life Sciences / Regulatory Affairs
Deliverable
client delivery
Required skills
Expert understanding of 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 and strategic thinking; Ability to manage complex international projects
Preferred skills
Ability to serve as lead in international Agency Interactions; Experience in bid defense and business development
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 to ensure compliance; Leads evaluation of new business opportunities and bid defense meetings; Embeds continuous improvement strategies for operational execution; Manages and develops staff; Defines and tracks functional KPIs; Anticipates and mitigates business risks
Seniority
Senior, strategic leadership