Director, Regulatory Affairs — Lifecycle & CMC Innovation

BioSpace; Indianapolis (IN); On-site; USD 177,000 - 282,000; Full time

Job summary

Lilly in Indianapolis seeks a Director of GRA-CMCD Lifecycle Innovation to lead post-approval CMC regulatory strategies across biologics and parenteral products. You will guide global teams, manage data packages, and ensure timely submissions.

The role emphasizes deep regulatory knowledge, collaboration with manufacturing and quality, and mentoring scientists, with responsibilities spanning strategy, filings, and lifecycle risk management.

Qualifications

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

Responsibilities

• Lead regulatory strategy for post-approval lifecycle activities across products and sites.
• Develop and implement post-approval regulatory strategies and filing approaches.
• Lead preparation and submission of variations, supplements, DMFs, and annual reports.
• Assess changes and deviations using risk-based principles for post-approval changes.
• Collaborate with Manufacturing and Quality to align data packages and timelines.
• Mentor regulatory scientists and teams as needed.

Skills

Regulatory leadership

CMC lifecycle experience

Cross-functional collaboration

Regulatory submissions

Risk assessment

Mentoring

Education

B.S. degree in a STEM field.

Advanced degree (MSc, PharmD, or PhD) in chemistry, biology, biochemistry, pharmacy, or a related scientific discipline preferred.

Job description

Lilly in Indianapolis seeks a Director of GRA-CMCD Lifecycle Innovation to lead post-approval CMC regulatory strategies across biologics and parenteral products. You will guide global teams, manage data packages, and ensure timely submissions.

The role emphasizes deep regulatory knowledge, collaboration with manufacturing and quality, and mentoring scientists, with responsibilities spanning strategy, filings, and lifecycle risk management.