Director, Global Regulatory CMC – Peptides & Oligos

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

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Job summary

Lilly in Indianapolis seeks a senior Regulatory CMC leader to guide development and manufacturing for synthetic peptides and oligonucleotides. The role spans regulatory strategy, global submissions, and lifecycle management, combining deep technical expertise with broad regulatory know-how.

You will lead cross-functional teams, influence decision-making across geographies, and ensure high-quality CMC documentation for clinical trials, registrations, and post-approval activities.

Qualifications

• 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of peptides, oligonucleotides, or related complex modalities.
• Experience authoring CMC submission content for peptides/oligonucleotides and participating in regulatory interactions.
• Knowledge of major global regulatory procedures, regulations, and evolving expectations for complex modalities.
• Experience planning for Health Authority interactions and managing risk in a regulated modality space.

Responsibilities

• Lead deep technical CMC development and lifecycle strategies for peptides and oligonucleotides.
• Provide regulatory guidance enabling CMC development teams to make informed decisions.
• Lead preparation, review, and approval of CMC documentation for global submissions and health authority responses.
• Ensure alignment across geographies, teams, and platform approaches.
• Support global product registrations and lifecycle management.
• Drive platform-based regulatory strategies and innovative approaches.

Skills

Regulatory CMC leadership

Global regulatory requirements

Cross-functional collaboration

Communication skills

Leadership

Education

B.S. in science/engineering

Advanced degree preferred

Job description

Lilly in Indianapolis seeks a senior Regulatory CMC leader to guide development and manufacturing for synthetic peptides and oligonucleotides. The role spans regulatory strategy, global submissions, and lifecycle management, combining deep technical expertise with broad regulatory know-how.

You will lead cross-functional teams, influence decision-making across geographies, and ensure high-quality CMC documentation for clinical trials, registrations, and post-approval activities.