Associate / Senior Associate / Manager - CMC Regulatory GRA

8w2 months ago

Eli Lilly and Company

Cork, IE · Contract · €55,000 – €110,000

About this role

At Lilly, we unite caring with discovery to make life better for people around the world. Eli Lilly Cork features a diverse team of over 2000 employees across 60 nationalities delivering innovative solutions in Finance, IT, Medical, and Clinical Trials. Come join our team - Be Creative, Be an Innovator, and Be Yourself.

This is a 12 month FTC. The Global CMC Regulatory Associate in GRA Regulatory Delivery and Excellence manages operational and technical CMC registration processes for expedited delivery of safe products. Scope covers CMC records from clinical trials through marketing application withdrawal.

Eli Lilly Cork offers a premium workspace in Little Island with flexible hybrid working options. Benefits include healthcare, pension, life assurance, subsidised canteen, onsite gym, travel subsidies, and on-site parking. Inhouse People Development, Educational Assistance, and ‘Live Your BEST Life’ wellbeing initiatives enhance career experience.

Eli Lilly Cork commits to diversity, equity, and inclusion with pillars: EnAble, embRACE, LGBTQ+ & Ally, and GIN-Gender Inclusion Network. EnAble partners with Access Lilly for accessible physical and digital environments. Together, they promote a disability confident culture at Eli Lilly Cork and beyond.

The Associate utilises CMC process expertise to drive consistency and change management within GRA and cross-functionally. They prioritise communications between Regional Submission Associates, GRA-CMC Scientists, RD&E Specialists, and Quality/Reg Representatives. Routine communication ensures submission tracking aligns with manufacturing needs.

Requirements

Solid understanding of regulations related to CMC, guidance, and CMC regulatory precedence
CMC process expertise and CMC product-specific knowledge
Expertise in CMC submission processes and Information Technology tools
Ability to expedite registration and lifecycle maintenance within regulations
Experience managing CMC records from clinical trials through marketing application withdrawal
Skills in global regulatory requirement assessment for CMC
Knowledge of coordinating CMC submissions across regulatory teams

Responsibilities

Accountable for operational and technical CMC registration management processes supporting expedited delivery of safe and effective products
Maintain strong understanding of regulations related to CMC, guidance, and CMC regulatory precedence
Build congenial relationships across Lilly components and partner companies
Utilise CMC process expertise and product-specific knowledge to drive internal consistency and influence change management
Prioritise and lead communications between Regional Submission Associates, GRA-CMC Scientists, RD&E Specialists, and Quality/Reg Representatives
Apply CMC submission process expertise and IT tools to develop project management expectations across projects
Responsible for routine communication of submission tracking requirements to GRA-CMC Scientists and internal customers
Conduct global regulatory requirement assessment and strategy development; coordinate submissions with RD&E specialists