Global Regulatory Affairs Director — CMC Lifecycle
eli lilly companyIndianapolis (IN)
Global Regulatory Affairs Director — CMC Lifecycle
Posted yesterday
eli lilly companyIndianapolis (IN)
SENIORITY
Manager
About the role
Lilly is seeking a Director, GRA-CMCD Lifecycle Innovation to provide scientific, strategic, and operational regulatory leadership for post-approval CMC activities across Lilly's parenteral product portfolio. This role drives lifecycle strategies, data package quality, and timely submissions with global teams across sites and CMOs.
Responsibilities include leading variations, assessing changes, coordinating with Manufacturing and Quality, and mentoring regulatory staff to ensure compliant,
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
More like this