CMC Specialist
Core
Manage Life Cycle Management (LCM) and regulatory CMC activities for Self Care medicinal products in EMEA, providing technical assessments and submission support.
Role type
CMC Specialist (Regulatory Affairs)
Builds
Regulatory submissions, CMC technical content, and compliance documentation for consumer health products.
Domain
Consumer Health / Pharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
CMC regulatory affairs, Life Cycle Management (LCM), regulatory submission preparation, risk assessment, change control, compliance management, cross-functional collaboration
Preferred skills
knowledge of EMEA regulatory guidelines, post-approval change management
Technologies
null
Responsibilities
Lead preparation of CMC information for regional regulatory submissions; review CMC changes for completeness and accuracy; oversee authoring of CMC documentation; manage commercial license status and product compliance; act as CMC representative in cross-functional teams; resolve regulatory issues and manage risks.
Seniority
Mid-level IC, reporting to Senior CMC Manager
