Global CMC Regulatory Leader – Small Molecules

BioSpace; Indianapolis (IN); On-site; USD 148,500 - 257,400; Full time

Benefits offered by this job

Relocation assistance

Remote option may be considered

Company bonus

Comprehensive benefits package

Job summary

Lilly in Indianapolis, IN is seeking a Regulatory CMC leader to drive global submissions and lifecycle strategies for small molecule programs. You will provide strategic and operational guidance across clinical trials, marketing applications, and post-approval changes in a highly regulated environment.

The role requires deep knowledge of CMC development, 10+ years of experience, and the ability to influence cross-functional teams while navigating global regulations.

Qualifications

• B.S. degree in a science, engineering, or STEM field; advanced degree preferred.
• 10+ years of Regulatory CMC experience supporting clinical development and/or commercialization.
• Experience authoring CMC submissions and coordinating global regulatory activities.

Responsibilities

• Provide strategic, tactical and operational regulatory CMC leadership across modalities and manufacturing technologies.
• Lead preparation, review, and approval of CMC documents for global regulatory submissions and responses.
• Develop and implement innovative regulatory strategies and platform approaches.
• Guide CMC development teams on lifecycle planning and risk assessment.
• Collaborate with cross-functional teams to align on regulatory strategy and timelines.

Skills

Regulatory CMC leadership

CMC leadership

Regulatory strategy

Cross-functional leadership

Clinical submissions

Education

B.S. in Science/Engineering/STEM

Advanced degree preferred

Job description

Lilly in Indianapolis, IN is seeking a Regulatory CMC leader to drive global submissions and lifecycle strategies for small molecule programs. You will provide strategic and operational guidance across clinical trials, marketing applications, and post-approval changes in a highly regulated environment.

The role requires deep knowledge of CMC development, 10+ years of experience, and the ability to influence cross-functional teams while navigating global regulations.