Global CMC Regulatory Strategy Director

Regulatory Jobs; Indianapolis (IN); On-site; USD 177,000 - 282,000; Full time

Benefits offered by this job

Company bonus

401(k) plans

Health, dental, vision benefits

Pension

Paid time off

Well-being programs

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Director of GRA-CMCD Lifecycle Innovation to lead post-approval CMC activities across biologics and parenteral products. You will shape global regulatory strategies, drive data package quality, and coordinate with sites and CMOs to ensure timely submissions.

Strong knowledge of global regulations, plus leadership and collaboration skills, are essential to guide lifecycle changes and continuous process improvements.

Qualifications

• 7+ years of Regulatory CMC or technical CMC experience supporting post-approval lifecycle management of biologics, parenteral products, or related complex modalities.
• Experience developing regulatory strategies and leading teams to timely submissions.

Responsibilities

• Provide regulatory leadership for post-approval CMC activities across products and sites.
• Lead regulatory strategy for lifecycle management and filing approaches.
• Coordinate data packages and submission timelines with sites and CMOs.
• Lead preparation, review, and execution of variations, DMFs, and annual reports.
• Assess changes with risk-based principles for post-approval activities.
• Mentor global regulatory affairs teams and partners across sites.

Skills

Regulatory strategy

Leadership

Cross-functional teamwork

Communication

Education

Bachelor's degree in STEM

Advanced degree preferred

Job description

Lilly, headquartered in Indianapolis, Indiana, seeks a Director of GRA-CMCD Lifecycle Innovation to lead post-approval CMC activities across biologics and parenteral products. You will shape global regulatory strategies, drive data package quality, and coordinate with sites and CMOs to ensure timely submissions.

Strong knowledge of global regulations, plus leadership and collaboration skills, are essential to guide lifecycle changes and continuous process improvements.