Global CMC Regulatory Director — Remote Strategy

Eli Lilly and Company; Indiana (PA); Hybrid; USD 148,500 - 257,400; Full time

Benefits offered by this job

Relocation assistance

Comprehensive benefits package

401(k) and pension plans

Job summary

Eli Lilly and Company is seeking a Regulatory CMC Expert in Indianapolis, IN, with the possibility of remote work. This role demands deep expertise in small molecule CMC drug development and significant regulatory experience. Candidates should possess a B.S. in a relevant STEM field and over ten years in regulatory CMC. The anticipated wage ranges from $148,500 to $257,400, accompanied by comprehensive benefits including 401(k) and healthcare. Join us in making life better for people worldwide.

Qualifications

• Ten or more years of regulatory CMC or technical CMC experience supporting clinical phases of development.
• Experience authoring CMC submission content.
• Knowledge of major market procedures and evolving regulatory initiatives.

Responsibilities

• Provide regulatory guidance to allow CMC development teams to make informed decisions.
• Lead preparation and approval of CMC documents for regulatory submissions.
• Assess and manage risk in a highly regulated environment.

Skills

Deep technical knowledge of small molecule CMC drug development

Regulatory CMC experience

Strong communication skills

Leadership and negotiation skills

Analytical thinking

Education

B.S. degree in a science or engineering field

Advanced degree preferred

Job description

Eli Lilly and Company is seeking a Regulatory CMC Expert in Indianapolis, IN, with the possibility of remote work. This role demands deep expertise in small molecule CMC drug development and significant regulatory experience. Candidates should possess a B.S. in a relevant STEM field and over ten years in regulatory CMC. The anticipated wage ranges from $148,500 to $257,400, accompanied by comprehensive benefits including 401(k) and healthcare. Join us in making life better for people worldwide.