Associate / Senior Associate /Manager CMC Regulatory Associate - GRA Regulatory Delivery Excellence

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.

Overview

The Global CMC Regulatory Associate, Global Regulatory Affairs (GRA) Regulatory Delivery and Excellence (RD&E) is accountable for the operational and technical CMC registration management processes that support the expedited delivery of safe and effective products to patients around the world. This is accomplished through a strong, solid understanding of regulations related to CMC, guidance, and CMC regulatory precedence and congenial and mutually positive relationships across Lilly components and partner companies.

The Global CMC Regulatory Associate utilises CMC process expertise and CMC product-specific knowledge to drive appropriate internal consistency and influence effective change management within GRA and cross-functionally. The scope of the work includes CMC records from the beginning of clinical trials through withdrawal of the marketing application.

The Associate works within regulations to expedite the registration and lifecycle maintenance of products. The Associate will prioritise and lead the communications between our Regional Submission Associates, GRA-CMC Scientists, RD&E Specialists, and the Quality/Reg Representatives. The Associate applies CMC submission process expertise and 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 RD&E specialists, and project management for marketed product support.

It is encouraged that this position accepts corporate transformation initiatives and represents GRA as a change ambassador.

Primary Responsibilities:

Regulatory & Drug Development Expertise

• Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including an extensive knowledge of ICH CTD and evolving global agency standards, CMC RA submission processes, electronic submission regulations and mentorship 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 inquiries and requests, and when vital, consults with CMC RA Scientist for mentorship to prepare responses to questions.

• Implement and, in some cases, interpret global regulations and mentorship’s and look to regulatory precedents in submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Regional Submission Associate, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.

• Partner with Regional Submission Associate to align on submission strategies and timeline for deliverables and lead communications between Regional Submission Associate, GRA-CMC scientists, RD&E specialists and Quality/Regulatory representatives.

Lead, Influence, Partner

• Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes

• Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies

• Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.

• Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.

Minimum Qualification Requirements:

• Bachelor’s Degree in a scientific or health sciences field (e.g., pharmacy, chemistry, or related scientific discipline)

• Knowledge of pharmaceutical drug development or industry-related experience preferred.