Global CMC Regulatory Lead, Submissions & Strategy

100 Eli Lilly and Company; Indianapolis (IN); Hybrid; USD 149,000 - 257,000; Full time

Benefits offered by this job

Remote option may be considered

Relocation assistance

Bonus eligibility

Job summary

Eli Lilly and Company in Indianapolis, IN, is seeking a regulatory CMC leader to drive technical strategy and execution across small molecule development and manufacturing. This role integrates with global teams to accelerate clinical trial applications, registrations, and post-approval activities.

You will provide high-quality regulatory advice, manage complex submissions, and influence product lifecycle decisions while navigating evolving global guidelines.

Qualifications

• 10+ years in regulatory CMC or technical CMC for synthetic molecules.
• Experience supporting clinical development and/or commercialization.
• Proven ability to develop regulatory strategies and regulatory submissions.

Responsibilities

• Provide regulatory CMC leadership across therapeutic modalities and manufacturing technologies.
• Lead preparation and review of CMC documents for global submissions.
• Guide development teams on lifecycle planning and decisions.
• Lead health authority communications and responses.
• Assess regulatory risk and provide clear regulatory advice to project teams.
• Collaborate with cross-functional teams to align regulatory strategies.

Skills

Regulatory CMC leadership

Global regulatory knowledge

Strategic regulatory planning

Communication skills

Cross-functional collaboration

Education

B.S. in science/engineering or STEM field

Advanced degree preferred

Job description

Eli Lilly and Company in Indianapolis, IN, is seeking a regulatory CMC leader to drive technical strategy and execution across small molecule development and manufacturing. This role integrates with global teams to accelerate clinical trial applications, registrations, and post-approval activities.

You will provide high-quality regulatory advice, manage complex submissions, and influence product lifecycle decisions while navigating evolving global guidelines.