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

Join Our Team at Eli Lilly Cork

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.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team – Be Creative, Be an Innovator, and most of all, Be Yourself!

Purpose

The Lifecycle Innovation group in GRA-CMCD is responsible for ensuring Eli Lilly and Company develops and delivers 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 achieve 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 applies 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.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any role/position can change over time and can include additional responsibilities not specifically described in the job description. Collaborate with your supervisor regarding your actual job responsibilities and any related duties that might be required for the role/position.

Regulatory & Scientific Expertise

• Deep technical knowledge of pharmaceutical manufacturing technology and processes, including biotech molecules and development portfolio. Recognised 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 achievements 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 minimise risk.
• Reviews and approves CMC documents for global regulatory submissions, including submissions for manufacturing changes, new products, line extensions, or renewals.
• Independently leads 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 categorise and prioritise 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.
• Recognised as a model of strong leadership behaviours, provides mentoring and coaching to regulatory scientists working on lifecycle activities. Leads critical 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 organisation (s), effectively increasing Lilly's visibility and influence on evolving regulatory positions. Identifies opportunities to simplify lifecycle processes or accelerate submissions; shares guidelines and contributes to global lifecycle improvement initiatives.
• Contributes to the implementation of digital tools supporting lifecycle management, including automated templates, digital submissions, and basic AI/ML applications. Help standardise 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.

Lead / Partner & Site Engagement

• Leads communication strategy for affiliates and/or senior management to manage submission requirements, mitigate risk, and maintain regulatory 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 facilitate the timely completion of product registration achievements.
• 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, decision-making, and inspection readiness.
• Contributes to cross-site alignment efforts to promote consistent lifecycle approaches.
• Builds and maintains strong relationships with Manufacturing, Quality, Platform Expertise, and Digital/Business Operations teams.
• Clearly communicates lifecycle strategies, risks, and timelines, translating regulatory implications for operational and business stakeholders.
• Supports annual business planning activities related to lifecycle scope.
• Contributes to cross-GRA forums that share regulatory insights and supports the development of corporate positions in response to evolving agency requirements and guidelines.

Minimum Qualification Requirements

• BSc, MSc, PharmD, or PhD in Chemistry, Pharmacy, Biology, Biochemistry, or related scientific field, 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.
• Proven ability to organize and analyze complex information.
• Track record of identifying, leading, and supporting business process improvement initiatives.
• Ability to work independently with minimal supervision.
• Strong written and verbal communication skills.
• Understanding and application of risk analysis principles.
• Consistent delivery of projects within agreed