Specialist - Regulatory Affairs - Operations 4A
Core
Implementing CMC regulatory strategies and preparing documentation for the worldwide marketing and lifecycle management of pharmaceutical products (small molecules and biologicals).
Role type
Specialist, Regulatory Affairs (Operations)
Builds
Regulatory CMC dossiers for commercial pharmaceutical products
Domain
Pharmaceutical industry, Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC regulatory strategy, authoring CMC documentation, reviewing scientific information for technical merit, project planning and execution, cross-functional collaboration, understanding of manufacturing/QA/QC processes
Preferred skills
Experience in RA/QA/QC systems, familiarity with SAP/Documentum/Veeva/LIMS/Spotfire/Power BI, knowledge of pharmaceutical manufacturing and analytical testing
Technologies
SAP, Documentum, Veeva, LIMS, Spotfire, Power BI, MS Office
Responsibilities
Implement CMC regulatory strategies for assigned products, author CMC documentation for initial registration and lifecycle submissions, review scientific information to assess technical merits, prioritize and execute projects according to timelines, coordinate with cross-functional teams on documentation and status reporting, participate in departmental improvement activities like SOP maintenance
Seniority
Specialist, hands-on IC