Global CMC Regulatory Director - Lifecycle Leader

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 177,000 - 282,000; Full time

Benefits offered by this job

Relocation assistance

Job summary

Lilly in Indianapolis, IN, seeks a Director of GRA-CMCD Lifecycle Innovation to lead post-approval regulatory activities for parenteral products. You will shape global lifecycle strategies, manage data packages, and drive timely submissions across sites and CMOs, partnering with cross-functional teams to ensure high-quality lifecycle outcomes.

Requirements include a STEM degree and 10+ years in regulatory CMC for biologics or parenteral products; advanced degrees preferred.

Qualifications

• B.S. degree in a STEM field required.
• 10+ years of Regulatory CMC or technical CMC experience supporting post-approval lifecycle management of biologics, parenteral products, or related complex modalities.

Responsibilities

• Provide regulatory leadership for post-approval CMC activities across parenteral products and manufacturing sites.
• Lead regulatory strategies for site additions and technology transfers.
• Manage submissions including variations, supplements, annual reports, DMFs, and related documents.

Skills

Regulatory CMC leadership

Lifecycle management

Cross-functional collaboration

Global regulatory knowledge

Education

B.S. in STEM

Advanced degree preferred

Job description

Lilly in Indianapolis, IN, seeks a Director of GRA-CMCD Lifecycle Innovation to lead post-approval regulatory activities for parenteral products. You will shape global lifecycle strategies, manage data packages, and drive timely submissions across sites and CMOs, partnering with cross-functional teams to ensure high-quality lifecycle outcomes.

Requirements include a STEM degree and 10+ years in regulatory CMC for biologics or parenteral products; advanced degrees preferred.