Job Title:
Advisor/Senior Advisor Global Regulatory Affairs CMC – Post Approval – Synthetic Molecule Drug Substances
Location:
Indianapolis, Indiana, United States
Job ID: R-84707
Category: Research & Development
Job Type: Full-Time, Regular
Company Overview:
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to discovering and delivering life-changing medicines worldwide.
Position Summary:
Lead post-approval regulatory CMC strategies for synthetic molecule drug substances, including small molecules, peptides, proteins, and oligonucleotides. Drive lifecycle regulatory plans, submissions, and ensure alignment with global regulatory requirements. Act as a key regulatory expert collaborating with cross-functional teams.
Key Responsibilities:
Leverage deep technical knowledge of synthetic molecule drug substance CMC science and manufacturing processes.
Develop global regulatory CMC strategies for post-approval changes and lifecycle management.
Collaborate with regulatory, manufacturing, quality, and project teams to meet submission milestones.
Provide regulatory guidance for global registrations and lifecycle planning.
Lead review and strategic decisions for CMC regulatory submissions across regions.
Basic Qualifications:
Bachelor’s degree in Chemistry, Pharmacy, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, Biochemistry, or related field.
7+ years regulatory CMC or technical CMC experience in synthetic molecule drug substance development, commercialization, or manufacturing.
Preferred Skills:
In-depth knowledge of synthetic molecule drug substances including small molecules, peptides, proteins, or oligonucleotides.
Experience with commercialization and post-approval regulatory submissions.
Familiarity with global regulatory procedures and evolving regulations.
Strong communication, leadership, negotiation, and teamwork skills.
Ability to manage risk in a regulated environment.
Location & Travel:
Position based in Indianapolis, IN (no remote option)
Minimal domestic travel
Compensation:
Salary Range: $121,500 – $198,000
Bonus eligibility based on performance
Comprehensive benefits including 401(k), pension, health, and wellness programs
Inclusion & Accessibility:
Lilly supports diversity and equal opportunity employment. Accommodation requests during the application process can be made here:
👉 Workplace Accommodation Request
Employee Resource Groups:
Supports ERGs including PRIDE, WILL, OLA, enAble, Veterans Leadership Network, and others.
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