Eli Lilly and Company
Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity
Eli Lilly and Company, Indianapolis, Indiana, us, 46262
Overview
Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity Join to apply for the
Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity
role at
Eli Lilly and Company . 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 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. The GRL is the primary interface and will represent GRA on GBD/global program team to ensure global input into development plans, provide solutions 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 - Initiate and Update Regulatory Strategy Document (RSD) Acquire input from the global regulatory team members to develop a global regulatory strategy which supports product development, registration, and lifecycle maintenance globally. Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecycle (including NILEX). Develop and implement innovative approaches and solutions, and drive acceleration strategies. Identify and effectively communicate regulatory risks. Lead Global Regulatory Team in the development of RSD(s) for assigned programs. Initiate and maintain regulatory strategy documents using team expertise and regulatory science knowledge. Integrate external information to develop robust, innovative regulatory strategies and solutions. Provide input for and attend key regulatory agency meetings, as needed, that could impact the global product strategy or brand. Enable discussion of the RSD and regulatory issues/challenges at the Regulatory Strategy Forum with the Global Regulatory Team. Continually expand therapeutic area knowledge. Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment. Monitor upcoming and recent approvals of competitive development programs/plans. Ensure strategic messaging and content of global regulatory submission documents. Provide regulatory direction in the development of the core data sheet and claims mapping to align commercial objectives with regulatory guidance and precedent. Ensure local strategies and solutions deliver to the global regulatory strategy and meet BU and brand goals. Provide timely communication updates to GBD teams and BU management and other internal stakeholders. Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications. Ensure clear two-way communication between GBD/global program team and Global Regulatory Team. Coach and facilitate a feedback culture within the Global Regulatory Team to develop team performance. Represent Regulatory on the GBD/Global Program Team and support development teams in strategic planning, trial design and registration strategies for all in-scope countries, bringing in regional, CMC and Device regulatory scientists as needed. Engage in, influence, and shape external environment initiatives related to portfolio assets. Create and foster strategic relationships with key external players to identify and anticipate opportunities for growth. Review corporate communications and press releases. Set direction with Global Marketing and GBD for development, review, and approval of promotional claims. Partner with Regulatory Product Communications reviewer to advise GBD on promotional strategy and to review/approve press materials and IR communications. Lead/Influence/Partner Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions. Model innovation, leadership, and regulatory excellence as described in Global Regulatory Affairs white papers. Participate in forums that share regulatory information across GRA components and Lilly teams. Constructively challenge teams to reach the best solutions and create an inclusive environment for robust business decisions. Serve as a mentor for GRA personnel. May have direct reports. Minimum Qualification Requirements Advanced scientific degree (PhD, PharmD) and 8+ years of industry-related experience in regulatory affairs and/or drug development OR Bachelor’s with 10+ years of industry-related experience in regulatory affairs and/or drug development Other Information/Additional Preferences Proven leadership with bold communication and conflict management skills. Experience in regulatory submissions and interactions in the US, EU, China and Japan; leadership across multiple countries. 10 years of industry regulatory affairs/drug development experience; direct experience in clinical and CMC regulatory sciences and the applicable therapeutic area. Knowledge of global regulatory procedures and evolving reform initiatives; strong understanding of integrated drug development processes and regulatory/business strategies. Strong written, spoken, and presentation communication; risk assessment and management abilities; negotiation and influence skills. Anticipated travel of 10-15%. 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. If you require accommodation to submit a resume, please complete the accommodation request form. 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. Our employee resource groups are open to all employees. Learn more about all of our groups. Actual compensation will depend on education, experience, skills, and geographic location. The anticipated wage for this position is $162,000 - $237,600. Full-time employees are eligible for a company bonus and a comprehensive benefits program including 401(k), pension, health benefits, flexible spending accounts, life insurance, leave, and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion. #WeAreLilly
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Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity Join to apply for the
Senior Director Global Regulatory Lead (Late Phase) - Diabetes and Obesity
role at
Eli Lilly and Company . 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 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. The GRL is the primary interface and will represent GRA on GBD/global program team to ensure global input into development plans, provide solutions 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 - Initiate and Update Regulatory Strategy Document (RSD) Acquire input from the global regulatory team members to develop a global regulatory strategy which supports product development, registration, and lifecycle maintenance globally. Ensure regulatory strategy is integrated into the development team plan from Candidate Selection to End of Product Lifecycle (including NILEX). Develop and implement innovative approaches and solutions, and drive acceleration strategies. Identify and effectively communicate regulatory risks. Lead Global Regulatory Team in the development of RSD(s) for assigned programs. Initiate and maintain regulatory strategy documents using team expertise and regulatory science knowledge. Integrate external information to develop robust, innovative regulatory strategies and solutions. Provide input for and attend key regulatory agency meetings, as needed, that could impact the global product strategy or brand. Enable discussion of the RSD and regulatory issues/challenges at the Regulatory Strategy Forum with the Global Regulatory Team. Continually expand therapeutic area knowledge. Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment. Monitor upcoming and recent approvals of competitive development programs/plans. Ensure strategic messaging and content of global regulatory submission documents. Provide regulatory direction in the development of the core data sheet and claims mapping to align commercial objectives with regulatory guidance and precedent. Ensure local strategies and solutions deliver to the global regulatory strategy and meet BU and brand goals. Provide timely communication updates to GBD teams and BU management and other internal stakeholders. Lead Global Regulatory Team consisting of regional regulatory scientists, GRA-CMC, GRA-Devices, GRA-RD&E, and GRA-Global Labeling and Product Communications. Ensure clear two-way communication between GBD/global program team and Global Regulatory Team. Coach and facilitate a feedback culture within the Global Regulatory Team to develop team performance. Represent Regulatory on the GBD/Global Program Team and support development teams in strategic planning, trial design and registration strategies for all in-scope countries, bringing in regional, CMC and Device regulatory scientists as needed. Engage in, influence, and shape external environment initiatives related to portfolio assets. Create and foster strategic relationships with key external players to identify and anticipate opportunities for growth. Review corporate communications and press releases. Set direction with Global Marketing and GBD for development, review, and approval of promotional claims. Partner with Regulatory Product Communications reviewer to advise GBD on promotional strategy and to review/approve press materials and IR communications. Lead/Influence/Partner Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions. Model innovation, leadership, and regulatory excellence as described in Global Regulatory Affairs white papers. Participate in forums that share regulatory information across GRA components and Lilly teams. Constructively challenge teams to reach the best solutions and create an inclusive environment for robust business decisions. Serve as a mentor for GRA personnel. May have direct reports. Minimum Qualification Requirements Advanced scientific degree (PhD, PharmD) and 8+ years of industry-related experience in regulatory affairs and/or drug development OR Bachelor’s with 10+ years of industry-related experience in regulatory affairs and/or drug development Other Information/Additional Preferences Proven leadership with bold communication and conflict management skills. Experience in regulatory submissions and interactions in the US, EU, China and Japan; leadership across multiple countries. 10 years of industry regulatory affairs/drug development experience; direct experience in clinical and CMC regulatory sciences and the applicable therapeutic area. Knowledge of global regulatory procedures and evolving reform initiatives; strong understanding of integrated drug development processes and regulatory/business strategies. Strong written, spoken, and presentation communication; risk assessment and management abilities; negotiation and influence skills. Anticipated travel of 10-15%. 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. If you require accommodation to submit a resume, please complete the accommodation request form. 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. Our employee resource groups are open to all employees. Learn more about all of our groups. Actual compensation will depend on education, experience, skills, and geographic location. The anticipated wage for this position is $162,000 - $237,600. Full-time employees are eligible for a company bonus and a comprehensive benefits program including 401(k), pension, health benefits, flexible spending accounts, life insurance, leave, and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs at its discretion. #WeAreLilly
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