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

Lifecycle Innovation Regulatory Scientist

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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 Lifecycle Innovation Regulatory Scientist, in partnership with senior GRA-CMCD colleagues, provides tactical and operational direction to expedite CMC lifecycle management of Lilly's portfolio and technical agenda by supporting market registration submissions and post-approval submissions. These activities are accomplished with a strong working knowledge of global regulations, guidelines, and regulatory precedence coupled with a strong technical knowledge of CMC development and manufacturing processes.

The Lifecycle Innovation Regulatory Scientist is responsible for networking with RDE CMC Regulatory Associates and site teams to ensure proper communication and adherence to workflows to deliver on-time product lifecycle management. The scientist also contributes to lifecycle innovation initiatives, including process improvement, digital enablement, and standardization efforts across the Lifecycle Innovation group.

Primary Responsibilities:

• Provide technical knowledge of pharmaceutical manufacturing technology and processes of solid oral products.
• Partner with GRA-CMCD Regulatory Scientists and Directors to manage outsourcing activities and contract manufacturers.
• Ensure successful preparation of CMC dossiers and variation packages to support product submissions, including variations, supplements, annual reports, DMFs, and related submissions.
• Develop, plan, and execute appropriate regulatory strategies and agreed-upon priorities through effective partnership with GRA-CMCD Regulatory Scientists/Directors and other functional representatives, such as TS/MS (process and technology transfers), Manufacturing, Quality Control, and Quality Assurance.
• Prepare CMC CTD content consistent with approved manufacturing changes, technical reports, and procedural requirements.
• Partner with GRA-CMCD Regulatory Scientists/Directors to plan and prepare submission content for marketed products to support management of post-approval changes for content reuse for Rest of the World countries.
• Support the definition of filing approaches and data expectations for site changes, analytical updates, specification changes, packaging/storage site additions, and related lifecycle activities.
• Manage submission timelines with relevant teams (e.g., supply chain, QC, Manufacturing, clinical teams), monitor approval status, and communicate change status to interested personnel in a timely manner.
• Partner with RDE CMC Regulatory Associates to effectively support product lifecycle maintenance such as site registrations, product and site renewals, as well as license expiry, where applicable.
• Manage authoring and content reviews of simple Responses to Questions (RtQs).
• In conjunction with RDE CMC Regulatory Associates and GRA-CMCD Regulatory Scientists, may be involved in the management of some GMP documents, if applicable.
• Review/approve regulatory documents such as full and core CMC Dossiers, variation packages, post-approval commitments with health authorities, and answers to questions received from health authorities.
• Support regulatory assessments for change controls and deviations for assigned products/sites, applying risk-based principles under the guidance of senior colleagues.
• Monitor emerging regulatory guidance related to lifecycle management and apply it appropriately to current strategies and submissions.
• Coordinate with manufacturing sites to ensure readiness and alignment on regulatory expectations and timelines for assigned activities.

Lead, Influence, Partner & Lifecycle Innovation:

• Create an environment within Global Regulatory and across CMC teams that encourages open discussion and constructively challenges teams to reach robust outcomes on project decisions.
• Leverage internal forums to develop and share regulatory expertise, meeting critical product registration timelines and electronic submission structure and content requirements.
• Demonstrate strong problem-solving skills, addressing regulatory issues and communicating lifecycle strategies, risks, and timelines clearly across functions, sites, and geographies; translate regulatory implications for operational stakeholders.
• Build strong 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, supporting site readiness for lifecycle activities.
• Participate in cross-site alignment efforts and help standardize templates, documents, and approaches to promote consistent lifecycle practices, share best practices, and drive efficiency.
• Contribute to implementation and adoption of digital tools supporting lifecycle management, including automated templates, digital submissions, and basic AI/ML applications.
• Support monitoring of post-approval change (PAC) cycle times and submission performance metrics.
• Identify opportunities to simplify lifecycle processes or accelerate submissions, and contribute to continuous improvement initiatives within the Lifecycle Innovation group.
• Support annual business planning activities for lifecycle scope, as required.

Basic Qualifications:

• Minimum a college degree (BSc), ideally an advanced degree (MSc, PhD, PharmD preferred), in a related biological, pharmaceutical, or life science field.
• Regulatory affairs experience in either a pharmaceutical or biotech setting.
• Understanding of global CMC regulations, lifecycle strategies, and post-approval change management principles.
• Experience with change control, deviation assessments, and post-approval filings is desirable.

Additional Skills and Preferences:

• Fully bilingual (English/Spanish).
• Strong knowledge of Manufacturing and Quality work processes as well as GMP compliance.
• Excellent verbal and written communication skills, with the ability to influence and develop others in an international matrix environment, demonstrating a wider business perspective.
• Fully proficient in RIM and in using common Microsoft applications to create and present work.
• Good organizational skills, with excellent attention to detail and the ability to prioritize and be self-motivating.
• Proven teamwork skills: works well collaboratively or as an individual contributor, and adapts to diverse interpersonal styles.
• Conscientious attitude.
• Ability to work across multiple sites or with CMOs.
• Demonstrated ability to support change initiatives and adopt new practices; interest in or experience with digital tools, automation, or process improvement initiatives is a plus.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $84,000 – $154,000.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right