Advisor, Senior Advisor – Regulatory CMC

Eli Lilly and Company

. Provide strategic, tactical, and operational regulatory CMC support across therapeutic modalities and manufacturing technologies .

Posted 9/28/2026full-timeBoston • Massachusetts • United StatesSenior💰 $168,000 - $268,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory CMC support, including the development and execution of global regulatory strategies, and possesses strong communication and negotiation skills to effectively collaborate across cross-functional teams in the pharmaceutical industry.

Highest-signal resume keywords

Regulatory CMC ExperienceGlobal Regulatory StrategiesCMC Submission Content AuthoringPharmaceutical Industry ExperienceCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Technical KnowledgeRegulatory ExpertiseDrug DevelopmentPharmaceutical ManufacturingChange ManagementRisk EvaluationRegulatory ComplianceSubmission PreparationLifecycle PlanningAnalytical Areas

Soft Skills

Attention to DetailEffective TeamworkNegotiation SkillsInfluence SkillsAdaptability

Industry Keywords

PharmaBiotechClinical TrialsMarket RegistrationsPost-Approval ActivitiesRegulatory GuidanceEmerging Regulatory TrendsHealth Authority InteractionsCross-Functional TeamsIndustry Forums

About the role

Key responsibilities & impact

Provide strategic, tactical, and operational regulatory CMC support across therapeutic modalities and manufacturing technologies
Support clinical trials, market registrations, and post-approval activities
Apply CMC technical knowledge and regulatory expertise to develop and execute global regulatory strategies
Ensure internal consistency, effective change management, and predictable regulatory outcomes
Build productive relationships across research, development, manufacturing, quality, regulatory, and partner organizations
Apply technical knowledge of CMC drug development and pharmaceutical manufacturing sciences across drug substance, drug product, and analytical areas
Develop, implement, and maintain global CMC regulatory strategies
Provide regulatory advice for development, manufacturing, and lifecycle planning decisions
Evaluate regulatory impacts, identify risks, and develop mitigation options
Lead preparation, review, and finalization of CMC documents for global regulatory submissions
Resolve technical or operational issues affecting submission timing, regulatory compliance, or product supply
Manage complex issues and propose risk-based regulatory solutions
Build relationships across regulatory, research and development, manufacturing, quality, and regional teams
Provide regulatory guidance and subject matter expertise to CMC teams
Mentor and serve as a resource within the regulatory CMC community
Incorporate regulations and guidance into processes, tools, templates, and training materials
Contribute to internal policy development and discussions on emerging regulatory trends
Participate in industry forums or working groups
Lead or support cross-functional teams developing and executing global CMC regulatory strategies
Review CMC development strategies, control strategies, and submission content
Collaborate with manufacturing sites, technical experts, and quality organizations
Support health authority interactions, briefing materials, and responses to questions
Communicate regulatory strategies, risks, and recommendations to stakeholders
Share regulatory knowledge, lessons learned, and best practices
Contribute to corporate positions and responses to proposed agency regulations and guidelines

Requirements

What you’ll need

Bachelor’s degree in sciences discipline, such as chemistry, biology, biochemistry, pharmacy or related scientific discipline
Minimum of 5 years regulatory CMC experience within pharma or biotech industry
7+ years pharmaceutical industry experience in CMC technical drug development
Prior experience authoring CMC submission content
Strong written, spoken and presentation communication skills
Negotiation and influence skills
Attention to detail
Effective teamwork skills and ability to adapt to diverse interpersonal styles

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
Certain time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities