Global Regulatory Affairs Director — CMC Lifecycle

Eli Lilly and Company; Indianapolis (IN); On-site; USD 177,000 - 282,000; Full time

Job summary

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,

Qualifications

• B.S. in a STEM field required.
• 7+ years regulatory CMC or technical CMC experience.
• Advanced degree preferred (MSc, PharmD, or PhD).

Responsibilities

• Provide regulatory leadership for post-approval CMC activities.
• Develop lifecycle regulatory strategies for assigned products/sites.
• Lead submissions and variations, reviews of CMC documents.
• Manage change controls and deviation assessments.
• Coordinate with sites and CMOs for data packages.
• Mentor regulatory scientists and cross-functional teams.

Skills

Regulatory CMC

Lifecycle management

Regulatory strategy

Data packages

Technology transfers

Cross-functional collaboration

Risk assessment

Regulatory submissions

Leadership

Education

B.S. in STEM

M.S./PhD preferred

Tools

DMFs

Global filings

Job description

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,