Role OverviewAs the Global Regulatory Lead (GRL), you will be the accountable decision maker for the development & execution of global regulatory strategies— from portfolio entry through end of life. You will build and lead the Global Regulatory Team, serve as the primary regulatory voice on the Global Brand Development (GBD) team, and own the relationship and interaction strategy with the US FDA.
What You Will Do
Develop and execute innovative global regulatory strategies, oversee US FDA submissions and agency interactions, lead regulatory representation on the GBD/global program team, and ensure local affiliate regulatory plans align to global strategy and business priorities.
Why It Might Be a Fit
This role requires deep knowledge of global regulatory procedures, experience with regulatory submissions and agency interactions, and strong leadership, negotiation, and stakeholder communication skills.
Requirements
- Advanced scientific degree (i.e. PharmD, PhD) and 8+ years of experience in regulatory affairs and/or drug development
- OR Bachelor’s or Masters and 10+ years of experience in regulatory affairs and/or drug development
Benefits
- Company bonus
- Comprehensive benefit program
- 401(k) plan
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
- Relocation assistance
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