Global Regulatory Affairs Director, CMC & Platforms

BioSpace; Indianapolis (IN); Hybrid; USD 149,000 - 257,000; Full time

Job summary

Lilly, headquartered in Indianapolis, seeks a strategic Regulatory CMC leader to guide global submissions and lifecycle decisions for small molecule programs. You will leverage deep CMC expertise to accelerate development, coordinate with cross-functional teams, and shape regulatory strategies across geographies to support clinical trials and registrations.

The role emphasizes leadership, technical depth, and effective communication, with a hybrid work option in Indianapolis and minimal US

Qualifications

• Experience authoring CMC submission content and working on regulatory applications.
• Knowledge of global CMC regulatory requirements and guidelines.
• Experience with synthetic molecule drug development and lifecycle strategies.

Responsibilities

• Lead regulatory CMC strategy across modalities and manufacturing technologies.
• Prepare, review and approve CMC documents for global submissions.
• Provide regulatory guidance to development teams for lifecycle planning.
• Influence decisions on CMC strategies across geographies.

Skills

Regulatory CMC

Leadership

Regulatory strategy

Cross-functional

Communication

Education

BS in science/engineering

Advanced degree preferred

Job description

Lilly, headquartered in Indianapolis, seeks a strategic Regulatory CMC leader to guide global submissions and lifecycle decisions for small molecule programs. You will leverage deep CMC expertise to accelerate development, coordinate with cross-functional teams, and shape regulatory strategies across geographies to support clinical trials and registrations.

The role emphasizes leadership, technical depth, and effective communication, with a hybrid work option in Indianapolis and minimal US