Sr. Specialist - Regulatory Affairs - Operations 4C
Core
Leading and executing CMC regulatory strategies for post-approval pharmaceutical products, managing lifecycle changes, and ensuring global regulatory compliance.
Role type
Senior Specialist, Regulatory Affairs (CMC)
Builds
Post-approval CMC submissions, lifecycle management dossiers, and regulatory responses for commercial pharmaceutical products.
Domain
Pharmaceutical industry, Regulatory Affairs, CMC (Chemistry, Manufacturing, and Controls)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy, post-approval change management, scientific rationale assessment, cross-functional collaboration, regulatory risk identification, MS Office, regulatory IT systems (Veeva Vault, RIMS)
Preferred skills
Product in-license/divestment due diligence, continuous improvement of regulatory processes, mentoring junior colleagues
Technologies
Veeva Vault, RIMS, MS Office
Responsibilities
Prepare and review data/documents for post-approval CMC submissions; coordinate CMC documentation for worldwide variations and supplements; collaborate with QA, QC, manufacturing, and supply chain teams; ensure timely approvals and product supply continuity; lead regulatory milestones across the product lifecycle.
Seniority
Senior, hands-on IC with leadership responsibilities
