Sr. Principal Scientist – Regulatory GRA-CMCD Full-time

Join Lilly's Lifecycle Innovation Group

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Purpose: The Lifecycle Innovation group in GRA-CMCD is responsible for ensuring Eli Lilly and Company develops and executes effective post-approval CMC regulatory strategies across its global commercial portfolio. The group drives lifecycle regulatory excellence by supporting manufacturing sites, enabling process simplification, accelerating submission efficiency, and applying innovative digital and regulatory approaches to post-approval change management. The purpose of the Sr. Principal Scientist/Advisor/Sr. Advisor role is to provide strategic, tactical, and operational direction in support of Lilly's marketed portfolio by developing successful regulatory strategies and submissions globally. To accomplish this, the scientist develops collegial and mutually productive relationships with CMC customers, including personnel within pharmaceutical manufacturing sites (e.g., Manufacturing Science and Technology, Quality Assurance, Production, Supply Chain), bulk manufacturing sites, and contract manufacturers whose material is used in Lilly products. The scientist utilizes CMC technical knowledge, regulatory expertise, and lessons learned across GRA-CMCD to drive internal consistency, influence effective change management, and contribute to lifecycle innovation and continuous improvement initiatives.

Primary Responsibilities:

• Deep technical knowledge of pharmaceutical manufacturing technology and processes, including biotech molecules and development portfolio.
• Recognized internally and externally for broad knowledge of global CMC regulatory requirements and guidelines for reporting post-approval changes and updating global product registrations.
• Develops and evaluates global CMC post-approval regulatory strategies in collaboration with regulatory, TS/MS, Manufacturing, Quality, Platform Expertise teams, and project personnel to enable timely completion of submission milestones leading to health authority approval.
• Defines filing approaches and data expectations for site changes, analytical updates, specification changes, packaging/storage site additions, and related lifecycle activities.
• Leads preparation, review, and execution of variations, supplements, annual reports, DMFs, and related submissions for assigned products and/or sites.
• Anticipates and resolves key technical or operational issues that could impact the function, CMC team, and/or submission timing.
• Provides consultation across the global regulatory network to assess CMC regulatory strategies and provide regulatory and technical expertise to strengthen submissions or minimize risk.
• Reviews and approves CMC documents for global regulatory submissions, including submissions for manufacturing changes, new products, line extensions, or renewals.
• Independently manages risky (i.e., technically challenging, political) problems and identifies creative and/or alternative solutions that support GRA-CMCD objectives and partner requirements.
• Leads regulatory assessments for change controls and deviations for assigned products/sites, applying risk-based principles to categorize and prioritize post-approval changes.
• Monitors emerging regulatory guidance related to lifecycle management and applies it appropriately to current strategies and submissions.
• Makes technical decisions on CMC regulatory issues, setting new company direction and impacting product submissions across geographies.
• Advises CMC customers, central and regional regulatory support, and management on resolving complex issues.
• Recognized as a model of strong leadership behaviors; provides mentoring and coaching to regulatory scientists working on lifecycle activities.
• Leads strategic initiatives to incorporate new regulations, guidance, and company positions into Lilly processes/guidelines, tools, and/or training materials, while building in efficiency.
• Advises Technical Steering teams and network forums for the development of complex regulatory strategies.
• Influences policy and emerging regulations worldwide for CMC issues (internally and externally).
• Leads initiatives within industry organization(s), effectively increasing Lilly's visibility and influence on evolving regulatory positions.
• Identifies opportunities to simplify lifecycle processes or accelerate submissions; shares best practices and contributes to global lifecycle improvement initiatives.
• Contributes to implementation of digital tools supporting lifecycle management, including automated templates, digital submissions, and basic AI/ML applications.
• Help standardize templates, documents, and approaches across sites to drive consistency and efficiency.
• Supports monitoring of post-approval change (PAC) cycle times and submission performance metrics to enable data-driven process improvement.
• Participates in selected external initiatives or regulatory reliance pilots when relevant.
• Leads communication strategy for affiliates and/or senior management to manage submission requirements, mitigate risk, and maintain regulatory commitment compliance.
• Monitors global regulatory news and provides interpretation and internal communication as appropriate.
• Leads technical and regulatory review forums to evaluate submission strategy and/or data acceptability.
• Independently develops complex global CMC regulatory strategies and networks for alignment across MIH, TS/MS, Quality, GRA, product teams, Manufacturing sites, and affiliates, as required, to enable timely completion of product registration milestones.
• Takes a proactive leadership role in the critical review of molecule-specific CMC development strategies and submission content for registration, post-approval changes, and response-to-question submissions.
• Effectively collaborates with Health Authority CMC reviewers at US FDA during scientific advice meetings or submission review and interacts with global Health Authorities, as required.
• Serves as a key regulatory point of contact for assigned manufacturing sites, supporting site readiness for lifecycle activities, site expansions, transfers, and new capabilities.
• Provides regulatory guidance to site leadership on planning, decisions, and inspection preparedness.
• Participates in cross-site alignment efforts to promote consistent lifecycle approaches.
• Build strong working relationships with Manufacturing, Quality, Platform Expertise teams, and Digital/Business Operations.
• Communicates lifecycle strategies, risks, and timelines clearly to sites and cross-functional partners; translates regulatory implications for operational and business stakeholders.
• Supports annual business planning activities for lifecycle scope.
• Participates in forums that share regulatory information across GRA components and in the development of corporate positions on, and in response to, proposed agency regulations and guidelines.

Minimum Qualification Requirements:

• BSc, MSc, PharmD, or PhD in Chemistry, Pharmacy, Biology, Biochemistry, or related scientific discipline, or bachelor's with equivalent experience.
• Pharmaceutical industry experience in a manufacturing environment, e.g., Manufacturing Sciences and Technology, Quality Assurance, Analytical Laboratories, or Manufacturing (7–10 years).
• Prior regulatory CMC experience (3–7 years) or equivalent combination of technical and regulatory guidance knowledge.
• Strong understanding of global CMC regulations, manufacturing sciences, GMP, and lifecycle strategies.
• Experience with change control, comparability, deviation assessments, and post-approval filings.
• Demonstrated strong interpersonal and leadership skills; ability to interact effectively within group and with customer base.
• Demonstrated ability to organize and analyze detailed information.
• Demonstrated ability to identify, drive, and support business process improvement initiatives.
• Demonstrated ability to work independently.
• Demonstrated strong written and verbal communication skills.
• Demonstrated ability to understand and apply risk analysis concepts.
• Demonstrated ability to deliver projects according to agreed-upon timelines.

Other Information/Additional Preferences:

• Excellent communication and cross-functional collaboration skills.
• Ability to identify regulatory opportunities and support operational improvement.
• Experience with digital tools, automation, or AI/ML applications is a plus.
• Ability to work across multiple sites or with CMOs.
• Demonstrated ability to support change initiatives and drive adoption of new practices.
• Ability to collaborate effectively with site teams and influence cross-functional partners.

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Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.