Global Regulatory CMC Advisor — Strategic Submissions

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

Job summary

Lilly in Indianapolis/Boston (hybrid) seeks an Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist to provide strategic regulatory CMC support for clinical trials, registrations, and post‑approval activities across modalities.

You will lead global CMC regulatory strategies, guide cross‑functional teams, and deliver robust submissions while anticipating risks and shaping regulatory outcomes.

Qualifications

• Bachelor’s degree in sciences discipline (e.g. chemistry, biology, biochemistry, pharmacy or related scientific discipline).
• Minimum of 5 years regulatory CMC experience within pharma or biotech industry.
• 7+ years pharmaceutical industry experience in CMC technical drug development.
• Prior experience authoring CMC submission content.
• Demonstrated strong written, spoken and presentation communication skills.
• Demonstrated negotiation and influence skills.
• Demonstrated attention to detail.
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Responsibilities

• Apply strong technical knowledge of CMC drug development and pharmaceutical manufacturing sciences across drug substance, drug product, and analytical areas.
• Demonstrates broad knowledge of global CMC regulatory requirements and guidelines for clinical trials, global registrations, and maintaining approvals.
• Develops, implements, and maintains global CMC regulatory strategies responsive to regulatory expectations and program needs.
• Provides high-quality regulatory advice to enable development, manufacturing, and lifecycle planning decisions.
• Leads preparation, review, and finalization of CMC documents for global regulatory submissions.
• Anticipates and resolves issues impacting submission timing, regulatory compliance, or product supply.
• Independently manages technically challenging issues and proposes risk-based regulatory solutions.
• Leads or supports cross-functional teams in the development and execution of global CMC regulatory strategies.
• Collaborate with manufacturing sites, technical experts, and quality organizations to resolve regulatory issues.
• Supports health authority interactions for CMC topics, including briefing materials and responses to questions.

Skills

Regulatory CMC expertise

Leadership

Written & verbal communication

Negotiation skills

Teamwork

Attention to detail

Education

Bachelor’s degree in sciences

Job description

Lilly in Indianapolis/Boston (hybrid) seeks an Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist to provide strategic regulatory CMC support for clinical trials, registrations, and post‑approval activities across modalities.

You will lead global CMC regulatory strategies, guide cross‑functional teams, and deliver robust submissions while anticipating risks and shaping regulatory outcomes.