Labeling Implementation Lead, 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

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.