Senior Associate - Regulatory Affairs, Oncology

Key Responsibilities

• Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
• Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
• Create and maintain product regulatory information and history documents through systems
• Appropriately archive regulatory documents and agency communications
• Collaborate with CROs / partners to support site initiation
• Complete regulatory forms to support agency communications
• Coordinate QC of regulatory documentation (e.g. briefing materials)
• Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
• Respond to specific requests from and communicate relevant issues to GRT
• Actively support regulatory compliance

Qualifications

• Masters degree
• Or Bachelors degree and 2 years of Regulatory Affairs experience
• Or Associates degree and 6 years of Regulatory Affairs experience
• Or High school diploma / GED and 8 years of Regulatory Affairs experience