Job Description

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. Were looking for people who are determined to make life better for people around the world.Detailed Description: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, USA. Our 39,000 employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of diseases, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We are looking for people who are determined to make life better for people around the globe.We are seeking a highly skilled Regulatory Domain Expert with a strong understanding of technology to join our team. The ideal candidate will have deep expertise in regulatory processes such as authoring, publishing, submission, and labelling, along with a strong grasp of regulatory requirements from authorities such as the FDA, EMA, and Health Canada. In addition, the candidate should possess a strong technical background with hands-on experience in industry-leading applications, particularly Veeva RIM, and have the ability to work effectively with stakeholders across business and IT.Key Responsibilities:Technology Integration & Management:Lead the integration and configuration of Veeva RIM and other regulatory software solutions to align with business requirements.Utilize knowledge of Veeva Configuration, Integration to customize and optimize the use of regulatory platforms.Ensure seamless integration of regulatory systems with other enterprise applications, facilitating efficient data flow and process automation.Collaborate with IT teams to implement full-stack/veeva development projects that enhance regulatory processes.Regulatory Expertise:Provide in-depth understanding of regulatory processes such as authoring, publishing, submission, and labeling.Ensure compliance with regulatory requirements from FDA, EMA, Health Canada, and other global regulatory bodies.Stay updated on industry trends and regulatory changes to ensure systems and processes remain compliant.Stakeholder Management:Engage with business stakeholders to understand their regulatory needs and translate them into technical requirements.Influence and manage expectations across various departments, ensuring alignment between business goals and technology solutions.Serve as a liaison between regulatory affairs and IT, ensuring clear communication and effective collaboration.Process Improvement & Compliance:Identify opportunities for process improvements within regulatory operations and implement technology-driven solutions.Ensure all integrated systems and solutions adhere to industry standards and best practices.Lead training and support initiatives to ensure users are proficient in utilizing regulatory systems.Required Skills:Education:Bachelors or Masters degree in Life Sciences, Regulatory Affairs, or required fieldsExperience:5+ years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry.Exposure to Veeva RIM configuration and integrationsExperience with full-stack development and a solid understanding of the software development lifecycle (SDLC).Familiarity with global regulatory processes, especially those of FDA, EMA, and Health Canada.Experience with other regulatory software platforms and tools.Proven track record of leading cross-functional projects and teams in a global environment.Skills:Strong technical aptitude and the ability to manage complex system integrations.Excellent problem-solving skills and the ability to work under pressure in a dynamic environment.Outstanding communication and interpersonal skills, with the ability to influence and manage stakeholders effectively.Strong project management skills with a focus on regulatory projects.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively Lilly) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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

Eli Lilly