Global Regulatory CMC Platform Scientist — Hybrid

Regulatory Jobs; Boston, Indianapolis (MA, IN); Hybrid; USD 168,000 - 268,000; Full time

Benefits offered by this job

Bonus eligibility

401(k) plan

Comprehensive benefits

Job summary

Lilly is seeking an Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist to provide regulatory CMC support across modalities.

The role is based in Indianapolis or Boston (hybrid) and involves leading global regulatory strategies and submissions with cross‑functional teams. Ideal candidates have 5+ years in regulatory CMC and 7+ years in pharma/biotech; strong communication, negotiation, and problem‑solving skills are essential.

Qualifications

• Bachelor's degree in sciences discipline.
• Minimum of 5 years regulatory CMC experience within pharma or biotech industry.
• 7+ years pharmaceutical industry experience in CMC preferred.
• Strong written, spoken and presentation communication skills; negotiation and influence.

Responsibilities

• Develop and execute global CMC regulatory strategies for diverse modalities.
• Lead preparation and review of CMC documents for global submissions.
• Provide regulatory guidance to cross‑functional teams to enable development, manufacturing and lifecycle planning.
• Collaborate with manufacturing, quality and regulatory groups to resolve issues and support timely submissions.

Skills

CMC regulatory

Regulatory strategy

Global submissions

Cross-functional leadership

Education

BSc in sciences

Job description

Lilly is seeking an Advisor/Sr. Advisor - Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist to provide regulatory CMC support across modalities.

The role is based in Indianapolis or Boston (hybrid) and involves leading global regulatory strategies and submissions with cross‑functional teams. Ideal candidates have 5+ years in regulatory CMC and 7+ years in pharma/biotech; strong communication, negotiation, and problem‑solving skills are essential.