Key skills
Communication
About this role
Role Overview
- Ensure the development of appropriate regulatory strategies and execution for assigned asset(s)
- Work with the Early/Medicine Development Team (EDT/MDT) to ensure a robust regulatory strategy is in place
- Proactively develop regulatory strategies and promote innovative regulatory approaches
- Lead regulatory interactions and the regulatory review processes
- Ensure effective interaction with local regulatory counterparts in priority markets
Requirements
- Bachelor’s degree in a biological, life science, or healthcare field
- Significant experience in regulatory affairs (10+ years)
- 5+ years experience across all phases of drug development and regulatory submissions
- Track record leading global or regional regulatory strategy and interactions with health authorities
- Experience working in complex matrix teams with clinical, CMC, commercial, and safety functions
- Strong written and verbal communication skills with ability to present clearly to senior leaders and regulators.
Benefits
- Health care and other insurance benefits (for employee and family)
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave