Sr. Director - Global Regulatory Lead - Neuroscience / Immunology

Senior Director Global Regulatory Affairs, Global Regulatory Lead

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Purpose : The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement 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. The GRL creates and leads the Global Regulatory Team (inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists) and is responsible for forming and maintaining a highly effective global regulatory team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional regulatory teams, are aligned to the Global Brand Development (GBD) / global program team and business priorities in terms of the program's value proposition, workflow, product labeling, risk management, and issues management. Accordingly, the GRL is the primary interface with and will represent GRA on GBD / global program team to ensure global input into development plans, provide solutions (created with the regulatory team) to development and regulatory barriers, and reflect and manage risks. The GRL will represent regional regulatory plans to the GBD / global program team and at stakeholder / governance meetings and is responsible for including GRA functional and regional experts as needed to inform development and manage issues. For preclinical and early clinical development programs, the GRL leads the US and Canada submissions and agency interactions. All other agency interactions will be the responsibility of the regional regulatory scientists.

Primary Responsibilities :

• Regulatory and Scientific Expertise

Develop, Update and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)

Obtain input from the global regulatory team members to develop a global regulatory strategy which supports product (including delivery device and relevant medical devices) development, registration, and lifecycle maintenance globally.

Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications. Ensures clear and transparent two-way communication between GBD / global program team and Global Regulatory Team.

Support development teams in strategic planning, trial design and registration strategies for all in-scope countries for assigned products / programs, bringing in regional, CMC and Device regulatory scientists as needed.

Determine and communicate submission and approval requirements and regulator expectations.

Creates and fosters strategic relationship with key external players to identify and anticipate opportunities for growth.

Set appropriate direction with Global Marketing and GBD team for development, review, and approval of promotional claims.

Exemplify Team Lilly behaviors : Include, Innovate, Accelerate, and Deliver in internal and external interactions.

Minimum Qualification Requirements :

Other Information / Additional Preferences :