Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls
Core
Provide CMC regulatory input and strategies to support development projects and marketed products in Pharmaceutical Diagnostics, developing and maintaining Quality sections of product dossiers (Module 2.3 and Module 3) throughout the product lifecycle.
Role type
Senior Regulatory Manager (Chemistry, Manufacturing, and Controls)
Builds
Regulatory submission packages and product dossiers for Pharmaceutical Diagnostics
Domain
Pharmaceutical Diagnostics / Regulatory Affairs
Required skills
CMC regulatory strategy, dossier development (Module 2.3/3), variation type definition, submission document review, global regulatory requirements knowledge, electronic document management, audit support
Preferred skills
Master's degree, injectable diagnostic experience, matrix organization navigation, Veeva RIM proficiency, strategic planning
Technologies
Veeva RIM
Responsibilities
Provide CMC strategic regulatory input for projects; Build submission strategy documents defining variation types and data requirements; Guide project teams on data collection for global markets; Review and write CMC submission documents; Maintain registration tracking; Support QA during audits; Advise on CMC variations impact
Seniority
Senior, hands-on IC