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Advisor/Senior Advisor Global Regulatory Affairs Cmc – Post Approval – Synthetic Molecule Drug Substances

7+ years
$121,500 – $198,000
10 June 4, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.