Sr. Director - Global Regulatory Lead - Neuroscience/Immunology

Lilly • Indianapolis, IN

62d • Onsite

About The Position

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 to include 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.

Requirements

• Advanced scientific degree (i.e., PhD, PharmD) and 8+ years Industry-related experience in regulatory affairs and/or drug development experience
• Bachelor’s degree with 10+ years of industry-related experience in regulatory affairs and/or drug development experience

Nice To Haves

• Proven experiences and leadership assignments demonstrating bold leadership, exemplary team attributes, effective communications with peers and executive leaders, and effective conflict management skills.
• Knowledge of Global regulatory procedures and practices and awareness of evolving regulatory reform initiatives desirable
• Demonstrated deep knowledge of the integrated drug development process and Lilly’s (or external peer company) regulatory/business strategies
• Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes
• Demonstrated ability to assess and manage risk in a highly regulated environment
• Strong written, spoken and presentation communication
• Demonstrated negotiation and influence skills
• Demonstrated attention to detail
• Experience in regulatory submissions and regulatory interactions in the US, EU, China and Japan
• Previous regulatory or leadership assignments across multiple countries
• Industry-related experience in regulatory affairs and/or drug development experience for 10 years
• Direct experience in clinical and CMC regulatory sciences
• Experience in applicable therapeutic area neuroscience and/or immunology

Responsibilities

• Develop, Update and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)
• Lead Global Regulatory Team
• Represent Regulatory on the GBD/Global Program Team
• For Preclinical and Early Clinical Development Programs: Lead and develop the US and Canada strategy for submission and amendments for IND, IDE, CTA
• Engage in, influence, and shape external environment initiatives related to portfolio assets
• Lead/Influence/Partner

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees