Global Regulatory CMC Strategist – Hybrid

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

Job summary

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

This role applies CMC regulatory expertise to develop and execute global strategies, ensuring timely and compliant submissions.

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

• Leads preparation, review, and finalization of CMC documents for global regulatory submissions
• Provides regulatory guidance to enable informed development, manufacturing, and lifecycle planning decisions
• Builds strong working relationships to drive alignment on CMC regulatory strategies
• Supports health authority interactions for CMC topics, including preparation of briefing materials and responses to questions
• Communicates regulatory strategies, risks, and recommendations clearly to team members and stakeholders
• Participates in forums to share regulatory knowledge and best practices across the organization
• Contributes to development of corporate positions and responses to proposed agency regulations and guidelines relevant to CMC

Education

Bachelor’s degree in sciences discipline

Job description

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

This role applies CMC regulatory expertise to develop and execute global strategies, ensuring timely and compliant submissions.