Sr. Associate/Manager - Regulatory CMCAt 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Purpose: The CMC Regulatory Associate (RA), Global Regulatory Affairs (GRA) Regulatory Delivery Excellence (RDE) leads, in partnership with the GRA-CMC Regulatory Scientists, the various aspects of global marketing authorization submission management processes. The RA also partners with GRA-CMC Scientists to help create and manage RIM submission content, and to provide guidance on structure and content placement within CTD registration submissions. The CMC Regulatory Associate works within regulations to expedite the registration and lifecycle maintenance of products.
Primary Responsibilities: Regulatory & Drug Development ExpertiseLead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards.Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.Lead, Influence, PartnerCreate an environment within the Global Regulatory Area that encourages open discussions on issues to achieve robust outcomes on project decisions.Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies.Minimum Qualification Requirements: Bachelor's Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline).Other Information/Additional Preferences: Knowledge of pharmaceutical drug development or industry-related experience preferred.Ability to operate and manage operational requirements in a regulated environment.Written, spoken, and presentation skills.Attention to detail and ability to effectively prioritize.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.
About UsAt Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.
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