The role involves leading the global regulatory CMC strategy for combination products from early development through post-marketing compliance
Job Summary
The role involves leading the global regulatory CMC strategy for combination products from early development through post-marketing compliance.
Candidates must provide technical guidance to ensure integration of global requirements into regulatory submissions aligned with FDA and EMA guidelines.
The position requires acting as the primary interface for cross-functional teams and external organizations to ensure successful approvals in key markets.
Matching Summary
The role involves leading the global regulatory CMC strategy for combination products from early development through post-marketing compliance.
Skills & Requirements
Must-have
Global regulatory CMC strategy leadership
21 CFR Part 4 and EU MDR expertise
Device and combination product submissions
Module 3 technical documentation authoring
Health Authority interaction management
Nice-to-have
Cross-functional team collaboration skills
Strategic risk analysis capabilities
Mentoring regulatory professionals
External industry forum participation
Key Requirements
Master degree or PhD in biotechnology or pharmaceutical sciences
Experience in pharmaceutical/biotechnology industry CMC and Device areas
Leadership experience in Regulatory CMC for combination products