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 Associate/Sr Associate/Manager/Sr Manager, Global Regulatory Affairs (GRA)-EMEA or GRA Americas-Regional Regulatory Scientist is accountable to support establishing the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the global regulatory strategy (i.e. RSD) and ensure local regulations and region/country business needs are included. The Associate/Sr Associate/Manager/Sr Manager, Global Regulatory Affairs (GRA)-EMEA or GRA-Americas Regional Regulatory Scientist is accountable to provide regional regulatory expertise in supporting the delivery of high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s). The Associate Director/Director is responsible for supporting meetings and other interactions with region/country regulators. Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. 1. Regulatory Expertise for Assigned Program/Product(s) in Region/Country • Provide region/country input and review of global strategic plans and global/regional submission plan and documents. • Provide support to Regional Regulatory Lead Scientist during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region). • Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content. • Provide support to Regional Regulatory Lead Scientist for meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions. • Support development of local/regional labelling strategy (product information and packaging) and help to network for alignment across region/affiliate team to enable timely completion of registration milestones (i.e. submission, approval, and launch). Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region/country. Provide support to Regional Regulatory Lead Scientist in leading team during negotiation with regulators by providing responses to labeling questions. • Ensure compliance with all applicable regulations and internal quality systems. • Provide up-to-date expertise on regional registration procedures. • Interpret and anticipate impact of new guidelines and work with Regional Regulatory Lead Scientist to initiate change in response to changing environment. • Own all regulatory activities in support of assigned marketed product(s) in the region/country. For regional regulatory scientist supporting the US: ▪ Work with Regional Regulatory Lead Scientist to set appropriate direction with Global Marketing and US Brand Team for development, review, and approval of promotional claims. ▪ Support Regional Regulatory Lead Scientist to partner with GRA-Product Communications reviewer and advise US Brand Team on promotional strategy For regional regulatory scientist supporting for EMEA: ▪ Ensure the registration needs for local patients in clinical trials are met for countries in the region/country Lead, influence and partner • Partner with Global Regulatory Leads to help solve development and regulatory issues impacting local registrations and when engaging with relevant business unit and development team on assigned programs/products. • Partner with Global Regulatory Leads to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for countries in assigned region. • Liaise with the affiliates to anticipate region/country specific issues, impact of labelling on promotion, pricing, and reimbursement. • Participate in regional meetings (commercial managers, medical directors) to ensure that regulatory strategy and issues are considered and to learn about their needs. • Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners. • Propose continuous improvement projects to simplify processes and increase productivity of work executed by affiliates and GRA • Represent the regulatory function on cross-functional non-product related projects • Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions. • Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. • Constructively challenge teams to reach the best solutions to issues. • Create and lead in an environment of equity and inclusion that encourages open discussions on issues to achieve a robust outcome on business decisions. Minimum Qualification Requirements: • Bachelor’s degree in scientific or health sciences discipline • Industry-related or other relevant work experience in 1-3 years • Knowledge of local/regional regulatory procedures and practices • Knowledge of the drug development process • Ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes • Ability to assess and propose ways to manage risk in a highly regulated environment • Demonstrated strong written, spoken and presentation communication • Developing negotiation and influence skills • Demonstrated attention to detail • Demonstrated ability to work independently Other Information/Additional Preferences: • Key Contacts: Project team members, Global Regulatory Leads and other global regulatory team members, regional marketing/medical, and affiliate regulatory representatives • Location: preferably in the region of support; preferably at a Lilly/LRL site 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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. WeAreLilly