Sr. Associate/Manager - Global CMC Regulatory Associate

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 a 12 month FTC.

Purpose:

The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery Excellence (RDE) leads, in partnership with the GRA-CMC RA Scientists, the various aspects of global marketing authorization submission management processes. The Associate also partners with GRA-CMC Scientists to help create and manage RIM/Leo/Regulus submission content, and to provide guidance on structure and content placement within CTD registration submissions, and to provide assistance with submission related Ministry of Health responses or Lilly affiliate questions.  The Associate works within regulations to expedite the registration and lifecycle maintenance of products. This is accomplished by a strong working knowledge of internal procedures, guidance’s, and regulatory precedence.  The Associate will triage and manage the communications between our Lilly Affiliates, GRA-CMC Scientists, Specialists, and the Quality/ Reg Representatives. The Associate utilizes GRA-CMC submission process expertise and their expertise with Information Technology tools to develop project management expectations across projects.   Based on implementation and supply chain needs within manufacturing, the Associate will be responsible for routine communication of submission tracking requirements to both GRA-CMC Scientists and internal customers.  The scope of work includes global regulatory requirement assessment and strategy development, coordination of submissions with the submission specialists, and project management for marketed product support.

Primary Responsibilities:

1. Regulatory & Drug Development Expertise

• Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
• 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.
• Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
• Responsible for triage of Lilly affiliate inquires and requests and when necessary, consults