Senior Global Regulatory CMC Advisor – Strategy & Submissions

Lilly Group; Indianapolis (IN); Hybrid; USD 168,000 - 268,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Pension

Medical benefits

Flexible benefits

Life insurance

Vacation

Job summary

Lilly is a global leader in biopharmaceuticals, headquartered in Indianapolis. This role sits in Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist, delivering strategic CMC regulatory support across modalities for trials, registrations, and post-approval activities.

Location options include Indianapolis or Boston with a hybrid work model. The incumbent will lead regulatory strategy development, collaborate with manufacturing and quality, and enable timely submissions while

Qualifications

• Bachelor’s degree in sciences discipline (e.g. chemistry, biology, biochemistry, pharmacy or related)
• Minimum of 5 years regulatory CMC experience within pharma or biotech industry
• Strong written, spoken and presentation communication skills
• Experience authoring CMC submission content

Responsibilities

• Lead or support cross-functional teams in the development and execution of global CMC regulatory strategies.
• Prepare, review, and finalize CMC documents for global regulatory submissions.
• Provide regulatory guidance and subject matter expertise to CMC teams and stakeholders.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory advice

Communication skills

Education

Bachelor’s degree in sciences

Job description

Lilly is a global leader in biopharmaceuticals, headquartered in Indianapolis. This role sits in Global Regulatory Affairs (GRA) – CMC Platform Regulatory Scientist, delivering strategic CMC regulatory support across modalities for trials, registrations, and post-approval activities.

Location options include Indianapolis or Boston with a hybrid work model. The incumbent will lead regulatory strategy development, collaborate with manufacturing and quality, and enable timely submissions while