Director, Global CMC Regulatory Lifecycle

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

Benefits offered by this job

401(k)

Pension

Vacation benefits

Flexible benefits

Life insurance

Job summary

Lilly is seeking a Director, GRA-CMCD Lifecycle Innovation to lead post-approval CMC regulatory strategies and execution for parenteral products. You will guide cross-functional teams, manage site transfers, and drive lifecycle plans across global sites.

Strong regulatory expertise and leadership are essential. The role emphasizes collaboration with sites, CMOs, and regulatory agencies, while advancing digital tools and efficient submission processes.

Qualifications

• BS in a STEM field is required.
• 7+ years in Regulatory CMC or technical CMC for post-approval lifecycle.
• Advanced degree preferred in chemistry, biology, biochemistry, pharmacy, or related field.

Responsibilities

• Provide regulatory leadership for post-approval CMC activities across parenteral products.
• Lead site additions and technology transfers with internal sites and CMOs.
• Develop and implement post-approval regulatory strategies for site changes and data updates.

Skills

Regulatory leadership

Cross-functional collaboration

Communication skills

Risk management

Project management

Education

B.S. in STEM

Advanced degree (MSc/PhD/PharmD) preferred

Tools

CMC regulatory guidelines

Global regulatory submissions

Job description

Lilly is seeking a Director, GRA-CMCD Lifecycle Innovation to lead post-approval CMC regulatory strategies and execution for parenteral products. You will guide cross-functional teams, manage site transfers, and drive lifecycle plans across global sites.

Strong regulatory expertise and leadership are essential. The role emphasizes collaboration with sites, CMOs, and regulatory agencies, while advancing digital tools and efficient submission processes.