Key skills
Communication
About this role
Role Overview
- Ensure the development of appropriate regulatory strategies and execution for assigned asset(s) consistent with Medicines Development Strategies/ Integrated Evidence Strategies.
- 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.
- Ensure implementation of the regulatory strategies in support of the project priorities.
- Lead regulatory interactions and the regulatory review processes.
- Advocate persuasively to senior leaders in GSK and in Health Authorities.
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