Job Title: Associate, Regulatory CMC
We are seeking a highly motivated and detail-oriented individual to join our team as an Associate, Regulatory CMC in the Regulatory Delivery Excellence (RDE) department. The successful candidate will play a key role in leading global marketing authorization submission management processes and partnering with GRA-CMC Scientists to create and manage Leo/Regulus submission content.
About Eli Lilly Cork:
Eli Lilly Cork is a diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across various Business Service functions, including Finance, Information Technology, Medical, Clinical Trials, and more. Our premium workspace in Little Island offers flexible hybrid working options, healthcare, pension, and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, and on-site parking.
Diversity, Equity, and Inclusion:
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. Our four pillars are EnAble, Age & Culture, LGBTQ+, and GIN-Gender Inclusion Network.
Key Responsibilities:
1. Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including ICH CTD and evolving global agency standards.
2. 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.
3. Drive the execution of submission planning for global registration and maintenance submissions.
4. Triage Lilly affiliate inquiries and requests and consult with CMC RA Scientist for guidance when necessary.
5. Implement and interpret global regulations and guidance to ensure final document content and structure align with local regulatory requirements.
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.
* Ability to operate and manage operational requirements in a regulated environment.
* Written, spoken, and presentation skills.
* Negotiation and influence skills.
* Attention to detail and ability to effectively prioritize.
* Proven effective teamwork skills; able to adapt to diverse interpersonal styles.
What We Offer:
Lilly is dedicated to helping individuals with disabilities actively engage in the workforce, ensuring equal opportunities when vying for positions. We do 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.