Senior Advisor, Regulatory Starting Material

Eli Lilly and Company

. Lead identification, justification, and regulatory strategy for Regulatory Starting Materials across drug substance synthetic routes .

Posted 10/23/2026full-timeRemote • United StatesSenior💰 $153,000 - $268,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC regulatory strategy, including authoring submissions and managing drug substance/API development. Proven ability to lead cross-functional teams and navigate regulatory requirements for starting materials and manufacturing processes.

Highest-signal resume keywords

CMC Regulatory StrategySynthetic/Process ChemistryRegulatory Submissions AuthoringLeadership in Drug Substance DevelopmentICH Q11 Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Starting Materials ManagementDrug Substance/API DevelopmentImpurity Control StrategyTechnology TransferCGMP ComplianceRisk AssessmentManufacturing OversightBatch Record ReviewProcess ChemistryRegulatory Guidance Monitoring

Soft Skills

LeadershipCross-Functional CollaborationScientific WritingCommunication Skills

Certifications & Qualifications

PhD in Chemistry or Chemical Engineering

Industry Keywords

INDsNDAsMAAsHealth Authority InteractionsNon-GMP/GMP BoundarySupplier QualificationRegulatory InspectionsDue Diligence ActivitiesManufacturing TimingInventory Management

About the role

Key responsibilities & impact

Lead identification, justification, and regulatory strategy for Regulatory Starting Materials across drug substance synthetic routes
Manage starting material resupply campaigns and scale-up efforts, including inventory, production forecasts, manufacturing timing, suite reservations, and contracting
Author and review CMC regulatory submission content, including Module 3 sections, briefing documents, and agency responses, for INDs, NDAs, and MAAs
Prepare and lead health authority interactions, including Type C meetings and scientific advice procedures
Partner with Process Chemistry and Analytical Development to evaluate synthetic routes, structural relevance, impurity fate-and-purge, and risk assessments
Define and document the non-GMP/GMP manufacturing boundary for drug substance processes
Lead technology transfer and process changes affecting RSM designation through commercial manufacturing readiness
Manage drug substance/API CMO and RSM supplier relationships, including technical oversight, site visits, supplier qualification, and dual sourcing
Monitor global regulatory guidance and agency precedent and update internal strategy, templates, and risk assessments
Collaborate with Regulatory Affairs, Quality, Supply Chain, and Manufacturing on timelines, submission readiness, and supply continuity
Support due diligence activities involving drug substance manufacturing routes and starting material risk
Provide subject matter expertise during regulatory inspections and audits
Build, lead, and mentor a team supporting RSM and drug substance CMC strategy activities

Requirements

What you’ll need

Advanced degree in chemistry, chemical engineering, or a related field; PhD strongly preferred
7+ years of relevant experience in CMC, process chemistry, or drug substance/API development and manufacturing, including leadership of starting material or CMC regulatory strategy programs
Experience supporting late-stage clinical and/or commercial drug substance programs
Deep working knowledge of ICH Q11 and applicable regional guidance governing Regulatory Starting Material selection and justification
Experience authoring and defending CMC regulatory submissions, including health authority interactions related to starting material or drug substance manufacturing strategy
Strong background in synthetic/process chemistry, route scouting, impurity control strategy, and structural relevance arguments
Experience managing drug substance/API CMOs and raw material suppliers, including batch record reviews and manufacturing oversight
Working knowledge of cGMP requirements and the GMP/non-GMP boundary
Experience supporting technology transfer from clinical to commercial scale preferred
Strong leadership, cross-functional collaboration, and scientific writing/communication skills
Ability to identify and address starting material-related risks affecting regulatory timelines, supply, or program success
Domestic and international travel required, approximately 10–20%

Benefits

Comp & perks

Company bonus depending, in part, on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
Employee resource groups open to all employees