Global Regulatory CMC Advisor: Strategy & Submissions

Eli Lilly and Company; Boston (MA); Hybrid; USD 168,000 - 268,000; Full time

Job summary

Lilly is seeking a Regulatory CMC Platform Regulatory Scientist to provide strategic and operational CMC regulatory support for clinical trials and market registrations. The role spans drug substance, product, and analytics, requiring strong cross-functional collaboration with research, development, manufacturing, and quality teams.

Location is hybrid with options in Indianapolis or Boston. The candidate should have a minimum of 5 years in regulatory CMC within pharma/biotech and excellent

Qualifications

• Bachelor's degree in sciences discipline required.
• Minimum of 5 years regulatory CMC experience within pharma/biotech.
• Strong written, spoken and presentation communication skills; negotiation abilities.

Responsibilities

• Lead development and execution of global CMC regulatory strategies.
• Provide timely regulatory advice to enable development, manufacturing, and lifecycle planning.
• Prepare, review, and finalize CMC documents for global submissions.
• Support health authority interactions with briefing materials and responses to questions.
• Collaborate with manufacturing, quality, and development teams to resolve regulatory issues.
• Incorporate new regulations and company positions into processes and templates.

Skills

Regulatory CMC experience

Cross-functional collaboration

Regulatory strategy

Regulatory writing

Education

Bachelor’s degree in sciences discipline

Job description

Lilly is seeking a Regulatory CMC Platform Regulatory Scientist to provide strategic and operational CMC regulatory support for clinical trials and market registrations. The role spans drug substance, product, and analytics, requiring strong cross-functional collaboration with research, development, manufacturing, and quality teams.

Location is hybrid with options in Indianapolis or Boston. The candidate should have a minimum of 5 years in regulatory CMC within pharma/biotech and excellent