Global Regulatory Associate (Interim) – Regulatory Delivery Excellence

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 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, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

This is an interim 6 month position.

Purpose:

The interim Global Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery and Excellence (RD&E), is accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients around the world. This is accomplished through a strong working knowledge of regulations, guidances and regulatory precedence and collegial and mutually productive relationships across Lilly components, partner companies, and within relevant ministries of health. The Associate utilizes process expertise and therapeutic area knowledge to drive appropriate internal consistency and influence effective change management within GRA and cross-functionally. The scope of the work includes records from the start of clinical trials through withdrawal of the marketing application. It is expected that this position embraces corporate transformation initiatives and represent GRA as a change ambassador.

Primary Responsibilities:

1. Provide Regulatory & Drug Development Expertise

• Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content. This includes but is not limited to all submission associates with INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD. This role may act to produce and submit eCTD submissions globally or regionally.
• Ensure incoming correspondence are archived accurately and related to appropriate records, assuring all metadata fields are complete in RIM.
• Partner with other geographies to understand and incorporate local agency regulations and requirements as needed. For example, lead the planning and execution for electronic submissions in those regions who have and are adopting the eCTD specification.
• Guide and influence development team and function regarding internal and Agency registration management processes and requirements.
• Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate. Records include IND and NDA submissions, tracking the status of pending applications and commitments, incoming correspondence, and records of contact.
• Serve as the RDE operational lead for registration planning and execution including but not limited to critical chain planning sessions and status updates, team ope