Senior Director – Global Regulatory Affairs

Eli Lilly and Company

Senior Director, Global Regulatory Scientist responsible for US regulatory strategy for assigned products. Leading efficient regulatory submissions and ensuring compliance with FDA requirements.

Posted 8/3/2026full-timeIndianapolis • 🇺🇸 United StatesSenior💰 $169,500 - $248,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Expertise in US regulatory strategy and compliance, with a strong background in drug development and regulatory affairs. Proven ability to lead regulatory submissions and negotiations with agencies like the FDA while ensuring alignment with global strategies.

Highest-signal resume keywords

Regulatory Strategy DevelopmentFDA Interaction LeadershipRegulatory Submissions OversightRisk Assessment and ManagementScientific Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsDrug DevelopmentLabeling Strategy DevelopmentRegulatory EvaluationsCompliance with US Regulations

Soft Skills

TeamworkNegotiation SkillsAttention to DetailProblem SolvingPresentation Skills

Certifications & Qualifications

PhDMDPharmD

Industry Keywords

Regulatory ProceduresIntegrated Drug Development ProcessRegulatory Reform InitiativesQuality SystemsBusiness Outcomes

About the role

Key responsibilities & impact

Establish and execute the US regulatory strategy and plan for assigned product(s)
Ensure local plan aligns to the global regulatory strategy and Global Regulatory Plans (GRP)
Operate within a dual-accountability structure
Provide regulatory leadership and oversight in delivering high quality and efficient regulatory submissions, approvals, and labeling
Lead and/or participate in meetings and interactions with FDA
Serve as a senior scientific resource for meeting preparation, briefing document development, and agency negotiation strategies
Define the scientific priorities and key deliverables for assigned program(s)
Lead development of labeling strategy for assigned product(s)
Ensure compliance with all applicable US regulations and internal quality systems for assigned product(s)
Perform regulatory evaluations of external business opportunities as requested by management

Requirements

What you’ll need

Advanced scientific degree (i.e., PhD, MD, PharmD) with at least 5 years OR Bachelor’s with at least 10 years of relevant industry-related experience in regulatory affairs and/or drug development
Knowledge of local/regional regulatory procedures and practices
Awareness of evolving regulatory reform initiatives, preferred
Demonstrated knowledge of the integrated drug development process and Lilly’s (or external peer company) regulatory/business strategies
Demonstrated ability to find solutions and alternatives through teamwork resulting in positive business outcomes
Demonstrated ability to assess and manage risk in a highly regulated environment
Strong written, spoken and presentation communication
Demonstrated negotiation and influence skills
Demonstrated attention to detail
Industry-related experience in regulatory affairs and/or drug development experience for 8 years (preferred)

Benefits

Comp & perks

eligibility to participate in a company-sponsored 401(k)
pension
vacation benefits
eligibility for medical, dental, vision and prescription drug benefits
flexible benefits (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)