Sr. Scientist / Principal Scientist - Global Regulatory Affairs – Solid Oral Products

Eli Lilly and Company • Carolina, PR

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About The Position

The Lifecycle Innovation group in Global Regulatory Affairs–Chemistry, Manufacturing, and Controls (GRA-CMCD) ensures effective post-approval CMC regulatory strategies across Lilly’s global commercial portfolio. The Lifecycle Innovation Regulatory Scientist provides tactical and operational direction for CMC lifecycle management by supporting market registration and post-approval submissions. The role applies knowledge of global regulations, guidelines, and regulatory precedents alongside technical knowledge of CMC development and manufacturing processes. It also coordinates with RDE CMC Regulatory Associates and manufacturing site teams to support communication, workflow adherence, and on-time product lifecycle management.

The scientist contributes to lifecycle innovation through process improvement, digital enablement, and standardization. Responsibilities include preparing and reviewing CMC dossiers and variation packages, developing regulatory strategies for post-approval changes, coordinating timelines and submission status, supporting site and product lifecycle maintenance, and communicating regulatory risks and expectations across functions and geographies. The role partners with senior GRA-CMCD colleagues and stakeholders in manufacturing, quality, supply chain, technology transfer, and digital operations.

The position requires at least a college degree in a related biological, pharmaceutical, or life science field and regulatory affairs experience in a pharmaceutical or biotechnology setting. The anticipated wage is $84,000–$154,000. Eligible full-time employees may receive a company bonus and comprehensive benefits, subject to plan eligibility and company terms.

Requirements

• Minimum college degree (BSc) in a related biological, pharmaceutical, or life science field.
• Regulatory affairs experience in a pharmaceutical or biotechnology setting.
• Understanding of global CMC regulations, lifecycle strategies, and post-approval change-management principles.

Nice To Haves

• An advanced degree (MSc, PhD, or PharmD) is preferred.
• Experience with change control, deviation assessments, and post-approval filings is desirable.
• Fully bilingual in English and Spanish.
• Strong knowledge of Manufacturing and Quality work processes and GMP compliance.
• Excellent verbal and written communication skills, with the ability to influence and develop others in an international matrix environment and demonstrate a wider business perspective.
• Proficiency in RIM and common Microsoft applications for creating and presenting work.
• Strong organization, attention to detail, prioritization, and self-motivation.
• Ability to work collaboratively or independently and adapt to diverse interpersonal styles; conscientious attitude.
• Ability to work across multiple sites or with CMOs.
• Ability to support change initiatives and adopt new practices; interest or experience in digital tools, automation, or process improvement.

Responsibilities

• Provide technical knowledge of pharmaceutical manufacturing technology and processes for solid oral products.
• Partner with GRA-CMCD Regulatory Scientists and Directors to manage outsourcing activities and contract manufacturers.
• Prepare CMC dossiers and variation packages for product submissions, including variations, supplements, annual reports, DMFs, and related submissions.
• Develop, plan, and execute regulatory strategies and priorities in partnership with regulatory colleagues and functional representatives.
• Prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.
• Plan and prepare submission content for marketed products to support post-approval change management and content reuse for Rest of the World countries.
• Support filing approaches and data expectations for site changes, analytical updates, specification changes, packaging or storage site additions, and related lifecycle activities.
• Manage submission timelines with relevant teams, monitor approval status, and communicate change status to interested personnel.
• Partner with RDE CMC Regulatory Associates on lifecycle maintenance, including site registrations, product and site renewals, and license expiries where applicable.
• Manage authoring and content reviews of simple Responses to Questions (RtQs).
• Review and approve regulatory documents, including CMC dossiers, variation packages, post-approval commitments, and responses to health authority questions.
• Support risk-based regulatory assessments for change controls and deviations for assigned products and sites, under senior colleague guidance.
• Monitor emerging lifecycle-management guidance and apply it to strategies and submissions.
• Coordinate with manufacturing sites to align on regulatory expectations and timelines.
• Encourage open discussion and constructive challenge across Global Regulatory and CMC teams to support robust project decisions.
• Use internal forums to develop and share regulatory expertise and meet product registration timelines and electronic submission requirements.
• Address regulatory issues and clearly communicate lifecycle strategies, risks, and timelines across functions, sites, and geographies; explain regulatory implications to operational stakeholders.
• Build working relationships with Manufacturing, Quality, Platform Expertise, and Digital/Business Operations colleagues.
• Serve as a regulatory point of contact for assigned manufacturing sites or products and support site readiness for lifecycle activities.
• Participate in cross-site alignment and standardization of templates, documents, and approaches; share best practices and promote efficiency.
• Contribute to adoption of digital lifecycle-management tools, including automated templates, digital submissions, and basic AI/ML applications.
• Support monitoring of post-approval change cycle times and submission performance metrics.
• Identify opportunities to simplify lifecycle processes or accelerate submissions and contribute to continuous improvement initiatives.
• Support annual business planning activities for lifecycle scope as required.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• 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 an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior