At 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 people around the world.

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.

Purpose:

The CMC (Chemistry, Manufacturing, and Controls) Specialist Global Regulatory Affairs (GRA), Regulatory Delivery and Excellence (RD&E) has the primary responsibility to support the completion of Module 1 CMC-related information and any regional information for all submissions where CMC support is required, e.g., new product submissions, product renewal submissions, post-approval changes, single product and multi product manufacturing site registrations renewals etc. This also includes the preparation and appropriate set-up of CMC documents in the Lilly regulatory information management system. 

In this role, the CMC Specialist closely monitors and manages the submission work in conjunction with the relevant country Affiliate representative and other relevant stakeholders such as CMC Reg Associates, Regional Submission Associates, Regulatory Scientists, and manufacturing sites such as ndianapolis, Fegersheim, Sesto, Kinsale or any additional Lilly sites, CMO’s and TPOs. 

The CMC Specialist is expected to provide business process knowledge and regulatory subject matter expertise as appropriate to all stakeholders.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

Functional & Technical Expertise

Contribute to the global submission strategy, by developing & utilizing appropriate Information management expertise & country specific knowledge to support the regulatory documentation required for all CMC elements of CTD module 1 and any regional information. 

Coordinate global registration activities and request/provide the necessary documentation to affiliates for registration of products in global countries. Duties include preparing/requesting, COAs, FDA Certificates of Pharmaceutical Product (CPPs), MOH GMP Certificates, monographs (US/PhEur) Disclaimers, Regulatory Letters and Declarations. 

Demonstrate in-depth understanding of content requirements, including awareness and understanding of CTD format (module 1), 

Responsible for preparing updates to CMC CTD content consistent with approved manufacturing changes and procedural requirements primarily for module 1 support. 

Responsible for communicating and adhering to document naming convention and classifications requirements, revision management, and documenting ‘reasons for revision’ to facilitate accurate record keeping. 

Knowledge of CMC regulatory requirements,

Oversee and manage activities to register new products and renew existing products in global markets. 

Provide support for DFT activities (Document finalization Test) for assigned products.

Decision Making, Influence, Partner

Monitor and track CMC Submission mailbox and take appropriate and timely action on assigned projects. 

Prioritize submissions based on due dates and ensure work is completed according to agreed timelines. 

Proactively progress submission support work for other Lilly sites and Lilly sponsored CMO’s.

Create and leverage key relationships internally and externally. Influence through established professional relationships is key to moving documents through government bureaucracies. 

Proactively influence and negotiate with both internal and external customers to meet critical product registration timelines.

Project Management

Oversee and manage activities to register new products and renew existing products in global markets.

Proactively influence and negotiate with both internal and external customers to meet critical product registration timelines.

Plan, track and record all steps of product submission activities using the appropriate information systems to obtain and record the various document and item requirements needed by the affiliate for each country’s registration. 

Manage tracking process for certification documents to ensure delivery and receipt.

Minimum Qualification Requirements:

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

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

Other Information/Additional Preferences:

Drug development process or Industry-related experience

Knowledge of Agency submission procedures and practices. Knowledge / awareness of emerging submission electronic standards.

Ability to operate and manage operational requirements in a regulated environment.

Written, spoken and presentation skills

Effective interpersonal skills.

Attention to detail and ability to effectively prioritize.

Proven effective teamwork skills; able to adapt to diverse interpersonal styles.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

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