Director, Global CMC Regulatory – Peptides & Oligos

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

Benefits offered by this job

Company bonus eligibility

401(k) with company matching

Pension plan

Medical, dental, vision benefits

Vacation and paid time off

Flexible benefits programs

Job summary

Lilly, headquartered in Indianapolis, Indiana, is seeking a senior CMC regulatory leader to drive global regulatory strategies for complex modalities. You will guide development teams, oversee CMC documentation for submissions, and partner across geographies to ensure consistent, high-quality regulatory outcomes.

The role requires deep CMC expertise, strong leadership, and a track record in regulatory submissions for peptides/oligonucleotides or related modalities.

Qualifications

• Deep technical knowledge of CMC for peptides/oligonucleotides and related modalities.
• Experience authoring CMC submission content for regulatory questions.
• Strong regulatory and cross-functional collaboration skills.

Responsibilities

• Lead preparation, critical review, and approval of CMC documentation for global regulatory submissions.
• Provide regulatory guidance enabling CMC development teams to optimize strategies.
• Influence and align CMC strategies across geographies and platforms.

Skills

Regulatory CMC expertise

Global regulatory strategies

Lifecycle planning

Regulatory submissions

Communication & leadership

Education

BS in science/engineering

Job description

Lilly, headquartered in Indianapolis, Indiana, is seeking a senior CMC regulatory leader to drive global regulatory strategies for complex modalities. You will guide development teams, oversee CMC documentation for submissions, and partner across geographies to ensure consistent, high-quality regulatory outcomes.

The role requires deep CMC expertise, strong leadership, and a track record in regulatory submissions for peptides/oligonucleotides or related modalities.