Base: $221,925 to $369,875; bonus/equity: annual b...
Hybrid
Regulatory strategy development
Drug development process
Regulatory agency interactions
Ensure the development of appropriate regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset Plan (IAP)
Job Summary
Ensure the development of appropriate regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset Plan (IAP).
Works with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the IAP and the Medicine Profile.
When a team leader Provides direct line management responsibility for TG staff.
Matching Summary
Ensure the development of appropriate regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy/ Integrated Asset Plan (IAP).
Salary
Base: $221,925 to $369,875; Bonus/Equity: annual bonus and eligibility for long term incentive; Benefits: health care, retirement, paid holidays, vacation, leave
Skills & Requirements
Must-have
regulatory strategy development
drug development process
regulatory agency interactions
global regulatory requirements
product labeling
Nice-to-have
ambitious for patients culture
accountable for impact
doing the right thing
innovative regulatory approaches
talent attraction and development
Key Requirements
Bachelor’s degree in life sciences
7+ years extensive experience
leading development, submission and approval activities
successful relationship with Health Authority
extensive knowledge of clinical trial requirements