Jobleads-US
East Hanover, NJ, USA
Biomedical Research Submission Management, Associate Director Job ID REQ-10037240 Feb 18, 2025 USA Summary #LI-Hybrid This position can be based in East Hanover, NJ or Cambridge, MA. The Biomedical Research Submission Management, Associate Director will lead the BR cross-functional submission sub-teams to project manage regulatory submissions ensuring that applications and dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations, guidance, Novartis SOPs and working practices and quality standards. They will also train and guide authors and contributors on regulatory submission requirements and have managerial responsibility for local submission manager team. Key Responsibilities: Managerial responsibility for local submission management team. Manage the preparation of the BR submission components regulatory submission dossiers such as NDA, MAA (i.e., high complexity submissions). Leads submission planning discussions, developing,...