Senior Manager, Regulatory Science CMC Complex
Core
Develop and execute global CMC regulatory strategies for complex pharmaceutical products across development and lifecycle management.
Role type
Senior Manager, Regulatory Science CMC Complex
Builds
Global regulatory submissions (NDA, ANDA, supplements, DMFs) and lifecycle management for complex dosage forms
Domain
Pharmaceuticals / Regulatory Affairs / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy, global regulatory requirements, cGMP, lifecycle management, complex dosage forms expertise, submission authoring, risk assessment, stakeholder management, project management
Preferred skills
Master's degree, experience with drug-device combinations, injectable products, respiratory products, NDA/ANDA/DMF submissions, European procedures
Technologies
Microsoft Office, regulatory document management systems
Responsibilities
Develop global CMC regulatory strategies, assess CMC requirements and risks, prepare and deliver regulatory submissions, lead responses to health authority questions, mentor project teams, manage regulatory commitments and timelines
Seniority
Senior Manager, strategic leadership with hands-on execution
