Senior Manager, Regulatory Strategy - Somerset
3 weeks ago
Job summary
Legend Biotech is a global biotechnology company developing advanced cell therapies across various technology platforms.
Responsibilities
- Lead global regulatory submissions including IND / CTAs amendments information requests Orphan Drug Applications DSUR / IB and Marketing Applications etc.
- Coordinate Agency meetings meeting package preparation provide strategic regulatory input on clinical development plans CMC strategies nonclinical programs support regulatory milestones manage regulatory queries commitments works with experts responses provides regular status updates identifies regulatory risks creates mitigation plans develops drafts components analyses position statements interprets health authority feedback proposes recommended paths forward internal discussion provides routine guidance applicable regulations guidances precedents manages day-to-day activities timelines assigned deliverables.
Job description
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