Associate / Senior AssociateGlobal Regulatory Affairs-Cork-Regulatory Delivery & Excellence-Global Publisher

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!

***12 month contract position***

Purpose:

The purpose of the Regulatory Delivery and Excellence (RD&E) Global Submission Publisher role is to: 

• execute and maintain global regulatory submissions from candidate selection through end of product lifecycle. 
• provide maintenance support as needed for submissions. 
• coordinate the creation and legalization of regulatory submission documents supporting registration activities across the international region 
• meet customer requirements by optimizing business processes, tools and ensuring implementation of the regulatory agency’s preferred electronic common technical document (eCTD) specifications in a quality way to promote timely review by the regulatory agency. 
• build eCTD and/or non-eCTD expertise and partner with Global Regulatory Associates, Regional Submission Associates, Affiliate Regulatory, other publishing centers, vendors, and/or other contributing areas to align on submission specific requirements and to ensure adherence to submission regulations and guidelines. 

Although submission publishing work is technical, producing dossiers is a cross-functional process demanding an environment 
of critical time frames and potentially changing priorities, and, therefore, a strong emphasis is placed on teamwork, 
communication, and self-management.

Execute submission workload

• Responsible for managing multiple submission types across assigned molecules.
  • Coordinate and communicate with Regulatory Associates to execute planned compliance and strategic submissions.
  • Proactively manage 30-day packets to ensure compliance.
• Review and monitor the RIM or Share Point Calendar for delivery of planned documents in support of submissions and proactively update document status to manage workload and provide information on specific documents’ status as it pertains to any specific submission ensuring submissions are proactively processed such that they are delivered according to the planned submission date.
• Escalate issues that may impact submissions and timelines.

Technical leadership for regulatory document legalizations 

• Coordinate/facilitate the creation of Authorization Letters, Power of Attorney letters, and other corporate administrative documentation to support registration activities, and develop/maintain related business process documentation 
• Coordinates apostille/legalization process for letters and certificates, as necessary Further develop and maintain ar