Associate - Labeling Implementation - North America

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 63,000 - 150,000; Full time

Job summary

Lilly in Indianapolis, IN is seeking an Associate for Global Regulatory Affairs Labeling Implementation - North America. You will drive timely labeling updates across the product lifecycle, collaborating with Regulatory, Printing, Manufacturing, and other partners to ensure accuracy and regulatory compliance.

The role requires a bachelor's degree and 3-5 years in biotech or pharma, with strong writing, communication, and cross-functional leadership.

Qualifications

• Bachelor’s degree is required.
• 3–5 years' experience in biotechnology or pharmaceutical industry.
• Authorized to work in the United States on a full-time basis (visa sponsorship not provided).

Responsibilities

• Lead labeling-related activities across the product lifecycle to meet timelines.
• Coordinate with cross-functional teams for labeling changes.
• Oversee proof copy and interactions with PPD.
• Train affiliates on labeling systems and processes.
• Monitor regulatory changes affecting labeling in North America.

Skills

Regulatory labeling

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's degree

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Organization Overview

At Lilly, we serve an extraordinary purpose.We make a difference for peoplearound the globeby discovering,developingand delivering medicines that helpthemlive longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

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 utilizes regulatory labeling process expertise across the organization and geographies to drive consistency and influence effective change management.

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.

Basic Qualifications

• Bachelor’s degree
• 3-5 years in the biotechnology or pharmaceutical industry
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Preferences/Other Information

• 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $149,600

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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