Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity

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 builds and leads the Global Regulatory Team (inclusive of GRA central functions, GRA-CMC, GRA-Devices, and regional regulatory scientists) and forms and maintains a highly effective global regulatory team. The GRL creates and maintains the Regulatory Strategy Document (RSD) and ensures local plans, built 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 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 to include GRA functional and regional experts as needed to inform development and manage issues.

Regulatory and Scientific Expertise :

• Develop, Update and Implement the Global Regulatory Strategy
• Lead Global Regulatory Team in the development of RSD(s) for assigned programs
• Continually expand therapeutic area knowledge
• Ensure strategic messaging and content of global regulatory submission documents
• Provide timely and effective communication updates to the GBD teams and BU management and other internal stakeholders, as appropriate
• Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications
• Communicate and share key information to enable seamless execution of global regulatory strategy and cross-functional shared learnings
• Represent Regulatory on the GBD / Global Program 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
• Engage in, influence, and shape external environment initiatives related to portfolio assets
• Creates and fosters strategic relationships with key external players to identify and anticipate opportunities for growth
• Review corporate communications press releases
• Set appropriate direction with Global Marketing and GBD team for development, review, and approval of promotional claims
• Partner with Regulatory Product Communications reviewer to advise GBD team on promotional strategy
• Partner with Regulatory Product Communications reviewer to review and approve press materials and IR communications

Lead / Influence / Partner :

Minimum Qualification Requirements :

Other Information / Additional Preferences :

Note : This role is Indianapolis-based (relocation is provided) Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.