Associate Director - Global Regulatory Affairs, Regional Regulatory

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.

At Eli Lilly Cork, 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 45,000 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 patients 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, Age & Culture, LGBTQ+ 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!

The Associate Director of Regional Regulatory Scientist provides direction, leadership, and technical/process expertise to the staff providing regulatory and scientific support for Lilly products at Cork GBS. The Associate Director in this position provides strategic input, focuses on the results, thinks critically and emphasizes and drives cross-functional team collaboration for achievement of Team Lilly goals and objectives. To achieve this goal, the GRA Associate Director uses their regulatory and submission expertise, a strong working knowledge of customers, internal procedures, guidances and regulatory precedence. The GRA Associate Director is responsible for recruitment, retention, resource assignment, staff development, and performance management. The GRA Associate Director is 
accountable for completion of regulatory support activities and identification and implementation of process improvements.

1. People Management 
• Recruit, develop, and retain a diverse and highly capable workforce. 
• Ensure robust individual training plans and timely completion of required training for direct reports. 
• Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgement-based decision making. 
• Remove barriers to ensure labelling and regulatory activities are completed accurately, timely, and in compliance with regulatory and quality system requirements. 
• Actively coach and mentor staff, including providing strategic guidance to staff on regulatory and labeling process questions. 
• Empower staff members to make logical decisions, resolve issues and execute tasks. 
• Manage workload based on portfolio prioritization and address implications to overall resource management and strategies. 
• Support and encourage a culture of innovation and model inclusivity to ensure diverse voices and ideas are heard and considered. 
• Provide mentorship for the managers in the GRA team and across the site.

2. Regulatory Delivery 
• Align regulatory/labeling strategy with molecul