Position Title: Advisor / Senior Advisor – Global Regulatory Affairs CMC (Post Approval, Synthetic Molecule Drug Substances)
Job ID: R-84707
Category: Research & Development
Job Type: Full Time, Regular
Location: Indianapolis, Indiana, USA
🌍 About Lilly
Purpose: Create medicines that give people new hope to get better, feel better, and live better.
Employees: Deliver life-changing medicines, improve disease understanding, and support communities through philanthropy and volunteerism.
🎯 Role Purpose
The Advisor / Senior Advisor will:
Leverage CMC technical knowledge and regulatory science expertise
Drive regulatory CMC strategies for post-approval lifecycle of Lilly’s commercial products
Develop innovative regulatory strategies to support product lifecycle and submissions
🧠 Key Responsibilities
1. Regulatory Strategy & Guidance
Develop and evaluate global CMC regulatory strategies in collaboration with regulatory, manufacturing, quality, and project teams
Provide guidance to CMC teams to enable informed decisions on global registrations and product lifecycle planning
Anticipate and resolve technical or operational issues impacting submission timing
2. Post-Approval Submissions & Compliance
Lead critical review of CMC development strategies and submission content for:
Post-approval changes
Line extensions or renewals
Responses to Health Authority questions
Ensure alignment with global regulatory requirements for synthetic molecules
3. Technical Expertise
Apply deep technical knowledge of synthetic molecule drug substance CMC science and manufacturing, including:
Conventional small molecules
Synthetic peptides, proteins, or oligonucleotides
Stay updated on global regulatory changes and evolving guidance
4. Leadership & Project Management
Independently manage challenging regulatory projects
Take proactive leadership roles in problem-solving and decision-making
Collaborate effectively with cross-functional teams
🎓 Qualifications & Requirements
Minimum Requirements
B.S. degree in Chemistry, Pharmacy, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, Biochemistry, or related field
7+ years of regulatory CMC or technical CMC experience in synthetic molecule drug substance development, commercialization, or manufacturing
Additional Skills / Preferences
Prior experience supporting post-approval submissions and commercialization
Knowledge of major market procedures, regulations, and evolving global initiatives
Experience participating in Health Authority meetings
Strong communication, leadership, negotiation, and teamwork skills
Ability to assess and handle risk in a highly regulated environment
Attention to detail and problem-solving aptitude
💰 Compensation & Benefits
Salary Range: $121,500 – $198,000
Eligible for company bonus
Comprehensive benefits including 401(k), pension, vacation, medical, dental, vision, flexible spending accounts, life insurance, wellness programs, and employee clubs
🔖 #WeAreLilly
Equal Opportunity Employer
Accommodations available for individuals with disabilities
Employee Resource Groups (ERGs) include: PRIDE, WILL, VLN, enAble, and more
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