Job Title
Advisor/Senior Advisor – Global Regulatory Affairs CMC – Post Approval – Synthetic Molecule Drug Substances
Location
Indianapolis, Indiana, United States
Company
Eli Lilly and Company
Category
Research & Development
Job Type
Full Time | Regular
Job ID
R-84707
Position Summary
Lilly is seeking a post-approval regulatory CMC scientist to join their Global Regulatory Affairs team. The scientist will leverage technical knowledge and regulatory expertise to drive regulatory CMC strategies and manage post-approval and lifecycle submissions for Lilly's synthetic molecule drug substances, including small molecules, peptides, proteins, and oligonucleotides. The role requires innovative regulatory strategies and collaboration across global functions to ensure timely product registrations and lifecycle management.
Key Responsibilities
Lead regulatory CMC strategy for synthetic molecule drug substances (small molecules, peptides, proteins, oligonucleotides).
Develop global CMC strategies and collaborate with regulatory, manufacturing, and quality teams.
Manage post-approval submissions, product lifecycle, and regulatory changes.
Provide guidance to CMC teams on regulatory decisions impacting global registrations.
Anticipate and resolve technical and operational issues that could delay submissions.
Review CMC development strategies and submission content for registration, line extensions, and renewals.
Ensure compliance with global regulatory guidelines for reporting changes and maintaining product registrations.
Manage complex projects and provide proactive leadership in regulatory strategy development.
Participate in Health Authority meetings and negotiations when necessary.
Education Requirements
B.S. degree in a science, engineering, or related field (e.g., Chemistry, Pharmacy, Biochemistry, Chemical Engineering).
7+ years of experience in regulatory CMC or technical CMC for synthetic molecule drug substances.
Additional Skills/Preferences
Deep technical knowledge of synthetic molecule drug substance development, commercialization, and manufacturing.
Regulatory CMC experience with post-approval submissions.
Knowledge of global regulatory requirements and evolving initiatives.
Experience with Health Authority meetings and negotiation.
Strong written and verbal communication, leadership, and negotiation skills.
Ability to assess and manage risk in a regulated environment.
Attention to detail and strong teamwork abilities.
Compensation
Anticipated Salary Range: $121,500 – $198,000 annually.
Eligible for company bonus program (based on company and individual performance).
Benefits
401(k) plan and pension
Vacation and paid time off
Medical, dental, vision, and prescription drug benefits
Flexible spending accounts (healthcare, dependent care)
Life insurance and death benefits
Wellness programs (EAP, fitness benefits, clubs and activities)
Other leave of absence benefits
Travel
Minimal travel within the U.S.
Equal Opportunity Employer
Lilly is an equal opportunity employer dedicated to diversity and inclusion.
Employee Resource Groups (ERGs)
Includes groups such as the Black Employees at Lilly, Organization of Latinx at Lilly (OLA), Lilly India Network, PRIDE (LGBTQ+ Allies), Women’s Initiative for Leading at Lilly (WILL), and others.
Accommodation
Applicants needing accommodations during the application process can request assistance via the Accommodation Request Form.
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