Global Regulatory Lead, Regulatory Strategy - Global Regulatory Affairs - Infectious Disease/Vaccine

About The Role

As 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 provide strategic and technical leadership to a cross-functional 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.

Key Responsibilities

• Develop and execute innovative global regulatory strategies, owning the Regulatory Strategy Document (RSD) from Candidate Selection through end of lifecycle
• Integrate competitive intelligence, health authority guidance, and product-specific regulatory advice
• Lead regulatory representation on the GBD/global program team; shape development plans and address regulatory barriers
• Ensure local affiliate regulatory plans align to global strategy and business priorities (labeling, risk management, issues management)
• Oversee US FDA submissions and agency interactions (INDs, NDAs, BLAs)
• Drive high-quality communications with FDA articulating scientific position
• Build relationships with FDA to support product registration goals
• Provide strategic direction to a cross-functional Global Regulatory Team (regional scientists, GRA-CMC, GRA-Devices, GRA-RD&E, Global Labeling)
• Foster transparent communication, feedback, and continuous development
• Represent GRA at stakeholder/governance meetings; mentor GRA personnel
• Build external stakeholder relationships; advise promotional strategy and review press/IR materials

Minimum Qualifications

• Advanced scientific degree (PharmD, PhD) and 8+ years in regulatory affairs and/or drug development
• OR
• Bachelor’s or Masters and 10+ years in regulatory affairs and/or drug development

Additional Preferences

• Global regulatory procedures knowledge; experience across US, EU, China, Japan
• Clinical and CMC regulatory science experience
• Leadership, negotiation, and executive-level communication skills
• Risk assessment/management experience; therapeutic area experience

Additional Information

• Travel: 10–15%

Benefits (as stated)

• Eligibility for company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.