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Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Purpose

The Associate - Global Regulatory Affairs (GRA) Labeling Implementation -North America drives the timely and high-quality implementation and maintenance of product labeling in the assigned country/region. This role develops collegial, mutually positive relationships across Regulatory, Printed Packaging Development (PPD), Manufacturing/Supply Chain, Global Packaging, Development, and other business partners. The Global Regulatory Affairs (GRA) Labeling Implementation u regulatory labeling process expertise across the organization and geographies to drive consistency and influence effective change management.  

Primary Responsibilities 

Labeling Implementation Leadership  

Lead, partner, and influence labeling-related activities throughout the product lifecycle to drive timely and efficient implementation of labeling changes ensuring regulator and internal timelines are met.  

Function as a delegate for Affiliate labeling implementation responsibilities outlined in the Labeling Development and Maintenance standard.  

Lead and monitor the implementation of updated or new labeling components into the market.  

Advise affiliates on responsibility for managing control and integrity of affiliate truth copy documents.  

Liaise with cross functional partners to handle multiple changes occurring simultaneously (e.g., GRA-CMC or site technical changes impacting labeling).  

Provide oversight for the proof copy approval process and interactions with PPD.  

Train and assist affiliates on the use of systems, tools, and processes.  

Act as a power user for key labeling systems such as BLUE, RIM, etc.  

Assist with deviations, escalations, and audits related to labeling implementation.  

Monitor new regulations and guidances for assigned country/region, assess impact with input from Regional Regulatory Scientists, Device Regulatory Scientists, and Labeling Process Owner, and track progress.  

Functional and Technical Expertise  

Maintain an understanding and expertise on local requirements, laws, and regulations related to labeling implementation.  

Act as a subject matter authority and resource for other GRA colleagues (e.g., Regional Regulatory Scientists, Device Regulatory Scientists, Product Communication reviewers) on labeling processes.  

Educate customers on regulatory requirements, roles / responsibilities, labeling best practices and the process to ensure timely implementation of new or revised labeling.  

Decision Making/Influence/Problem Solving  

Serve as a labeling resource for regulatory to develop and gain support for strategies and concepts that will deliver timely labeling for marketed products.  

Apply knowledge of business processes and labeling to gain alignment with partners on standardized processes and labeling deliverables.  

Process information and team dynamics and adapt a style when negotiating with cross functional partners to enable effective decision making and timely completion of deliverables.  

Impact  

Drive timely implementation of labeling changes ensuring regulatory and internal timelines are met.  

Demonstrate understanding of labeling implementation process and understand impact. Communicate impact of labeling changes to cross-functional partners.  

Collaborate with Regulatory team on submission and implementation plans to capitalize upon opportunities for bundling changes for more efficient implementation, when applicable.  

Customer / External Focus  

Routinely share labeling knowledge with key customers. Participate in internal working groups to make recommendations that may shape regulatory labeling environment.  

Identify appropriate customers and partners to communicate impact of labeling changes. Anticipate questions and proactively communicate possible impact to labeling.  

Minimum Qualification Requirements 

Bachelor’s degree  

Additional Preferences/Other Information 

3-5 years in the biotechnology or pharmaceutical industry 

Scientific or health sciences degree field preferred (or equivalent work experience)  

Knowledge of local regulatory procedures and practices and awareness of evolving regulatory reform  

Understanding of manufacturing and supply chain practices  

Knowledge of drug development  

Project management experience  

Demonstrated ability to lead, influence and partner cross-functionally  

Demonstrated capability for contributing on complex projects with accelerated timelines  

Demonstrated strong communication skills: writing, presenting, listening.  

Shown flexibility to handle multiple tasks simultaneously  

Proven competence of computer skills (e.g., Word, Excel, PowerPoint)  

Demonstrated agility to learn new computer systems and tools, attention to detail and organizational skills, and ability to work independently  

Demonstrated effective teamwork abilities, adaptability to diverse interpersonal styles, and problem-solving skills  

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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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