Senior Director Global Regulatory Lead (Early Phase) - Oncology

Position Overview

• Location Type: Primarily Remote (may require occasional travel)
• Job Type: Full-time
• Salary: Not specified
• Purpose: The Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is responsible for developing and implementing innovative global regulatory strategies for product(s) in the assigned therapeutic area. The GRL is the accountable decision maker for the development & execution of global regulatory strategies from portfolio entry to end of life cycle to ensure strategies meet global business objectives and regional/local affiliate requirements.

Requirements

• Not specified

Responsibilities

• Develop, Update and Execute the Global Regulatory Strategy: Initiate and Update Regulatory Strategy.
• Obtain Input: Gather input from the global regulatory team members to develop a global regulatory strategy that supports product development, registration, and lifecycle maintenance globally.
• Integration: Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecyle (including NILEX).
• Innovative Approaches: Identify and effectively communicate regulatory risks.
• Lead Global Regulatory Team: Create and lead the Global Regulatory Team and is responsible for forming and maintaining a highly effective global regulatory team.
• Interface with Brand Development: Serve as the primary interface with the Global Brand Development (GBD)/global program team to ensure global input into development plans, provide solutions to development and regulatory barriers, and reflect and manage risks.
• Regional Regulatory Plans Alignment: Ensure local plans, created by the regional regulatory teams, are aligned to the brand development/global program team and business priorities.
• Stakeholder Representation: Represent regional regulatory plans to the GBD/global program team and at stakeholder/governance meetings.
• US & Canada Submissions (Early Development): Lead US and Canada submissions and agency interactions for preclinical and early clinical development programs.
• Regional Regulatory Support: Regional regulatory scientists are responsible for all other agency interactions.

Company Information

• Company: Lilly (Lilly, Inc.)
• Headquarters: Indianapolis, Indiana
• Mission: To unite caring with discovery to make life better for people around the world.
• Description: A global healthcare leader dedicated to discovering and bringing life-changing medicines to those who need them, improving the understanding and management of disease, and giving back to communities through philanthropy and volunteerism.