Global CMC Regulatory Leader — Senior Advisor

BioSpace; Boston (MA); Hybrid; USD 168,000 - 268,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision

Job summary

Lilly, headquartered in Indianapolis, invites applications for Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist. This role provides global regulatory strategies and technical CMC support across modalities for clinical trials, market registrations, and post-approval activities.

Location: Indianapolis or Boston (hybrid). Responsibilities include developing global CMC regulatory strategies, leading preparation of CMC submissions, guiding cross-functional

Qualifications

• Bachelor’s degree in sciences discipline required.
• Minimum of 5 years regulatory CMC experience in pharma/biotech.
• 7+ years pharma industry experience in CMC preferred.
• Strong written, spoken and presentation communication skills.
• Negotiation and influence skills; attention to detail.

Responsibilities

• Lead cross-functional teams to develop global CMC regulatory strategies.
• Review and finalize CMC submission content for regulatory filings.
• Collaborate with manufacturing, quality and regulatory partners to resolve issues.
• Support health authority interactions with briefing materials and responses.

Skills

CMC Knowledge

Regulatory Strategy

Global Submissions

Cross-functional Leadership

Regulatory Guidance

Education

Bachelor’s degree in sciences

Job description

Lilly, headquartered in Indianapolis, invites applications for Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist. This role provides global regulatory strategies and technical CMC support across modalities for clinical trials, market registrations, and post-approval activities.

Location: Indianapolis or Boston (hybrid). Responsibilities include developing global CMC regulatory strategies, leading preparation of CMC submissions, guiding cross-functional