Regulatory Project Manager, Strategy - CMC RA Small Molecules Mature Products
Core
Provide CMC regulatory support for a portfolio of marketed small molecule drug substances and products to ensure global supply continuity and compliance.
Role type
Senior IC Regulatory Project Manager (Strategy - CMC)
Builds
Regulatory variation dossiers, lifecycle maintenance submissions, and responses to agency questions for small molecule products.
Domain
Biopharmaceuticals / Small Molecules / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> regulatory filings and variation dossiers
Required skills
CMC regulatory strategy, lifecycle management, US FDA submission preparation, GMP compliance, cross-functional collaboration, regulatory risk management
Preferred skills
Advanced degree (Master's/PhD), leading FDA interactions, managing multiple product dossiers, stakeholder negotiation, inspection support
Technologies
Electronic dossier formats
Responsibilities
Develop CMC strategies for submission documents, prepare and quality-check CMC content for regulatory filings, act as primary US regulatory contact for agency interactions, advise cross-functional teams on US CMC requirements, manage regulatory risk by identifying gaps and proposing mitigations, share CMC expertise to improve regulatory processes
Seniority
Senior, hands-on IC
