At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana.
We have 41,000 employees worldwide who work together 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.
About Our Team
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 various business service functions, including finance, information technology, medical, clinical trials, and more.
Our Benefits
We offer 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.
Our Commitment to Diversity, Equity, and Inclusion
We are committed to diversity, equity, and inclusion (DEI) and cater for all dimensions, ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities, and gender.
About the Role
The Global Regulatory Associate will be accountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients.
This role requires a strong working knowledge of regulations, guidance's, and regulatory precedence, as well as collegial and mutually productive relationships across Lilly components, partner companies, and within relevant ministries of health.
Key Responsibilities
* Provide Regulatory & Drug Development Expertise:
o Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content.
o Partner with other geographies to understand and incorporate local agency regulations and requirements as needed.
o Guide and influence development team and function regarding internal and Agency registration management processes and requirements.
* Lead/Influence/Partner:
o Develop collaborative relationships with personnel in other Lilly functional areas to effectively influence the electronic registration plan.
o Create an environment within team and GRA that encourages open discussions on issues to achieve a robust outcome on project decisions.
o Develop collegial, mutually productive relationships with the FDA Office of Business Informatics to ensure understanding of the Agency's internal process and requirements.
Requirements
To be successful in this role, you will need a BS or higher degree in a technical discipline such as chemistry, biology, pharmacy, or equivalent demonstrated industry experience, as well as knowledge of drug development process and Lilly regulatory/business strategies and plans.
You will also need quick learning agility, retention of knowledge, strong project management skills, flexibility, and organizational skills, as well as previous project management and global submission experience.