Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufactu ...

Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices-EMEA

Purpose

To provide strategic, tactical, and operational direction to expedite CMC development of Lilly's portfolio and to develop successful regulatory strategies to support market registrations and product life cycle maintenance in the EMEA region, including the EU, CEE, META, Switzerland, and the United Kingdom.

• Primary Responsibilities
• Demonstrate technical knowledge of CMC drug development, including drug substance and drug product manufacturing, quality systems, and compliance.
• Maintain recognized expertise in EMEA regional CMC regulatory requirements, guidelines, and regulatory precedents.
• Develop and update regulatory strategy, evaluating regulatory impact of proposed CMC development plans and post approval change agendas.
• Provide high quality, timely regulatory advice to enable well informed decisions on development or product life cycle planning.
• Review CMC documents for EMEA submissions and coordinate with GRA CMCD to assess impacts of manufacturing changes, new products, or line extensions.
• Anticipate and resolve key technical or operational issues that could impact the function or CMC team.
• Participate in risk benefit analysis for regulatory compliance and influence internal policy development.
• Build awareness and alignment on CMC regulatory strategies across GRA, GRA CMCD, and regional affiliates.
• Participate in industry organizations to enhance Lilly's visibility and influence evolving regulatory positions.
• Coordinate preparation, review, and finalization of CMC documents for registrations and responses to questions in the EMEA region.
• Take proactive leadership in the critical review of molecule specific CMC development strategies and submission content.
• Collaborate with EMEA regional colleagues, GRA, GRA CMCD, and other functional areas (PR&D, M&Q) to support open discussion of issues and influence drug development strategies.
• Ensure timely EMEA regional submissions and communicate effectively to influence stakeholders within the function and broader organization.
• Participate in forums sharing EMEA regional regulatory information across GRA components and contribute to corporate positions on proposed agency regulations and guidelines.
• Minimum Qualification Requirements
• College degree (BSc) in chemistry, biology, biochemistry, or pharmacy; an advanced degree (MSc, Ph D, Pharm D) preferred.
• Minimum 4 years of pharmaceutical industry experience in technical drug development and/or medical device.
• Full professional proficiency in English (written and spoken).
• Strong written, spoken, and presentation communication skills.
• Negotiation and influence skills.
• Attention to detail and effective teamwork skills; ability to adapt to diverse interpersonal styles.
• Other Information / Additional Preferences
• Prior experience authoring CMC submission content.
• Prior regulatory CMC experience (5-8 years) or equivalent combination of technical and regulatory guidance knowledge.

EEO Statement

Eli Lilly and Company, Lilly USA, LLC, and our wholly owned subsidiaries (collectively "Lilly") are committed to providing equal employment opportunities and to ensuring a diverse workforce.

Lilly is an EEO/Affirmative Action Employer and 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.

If you require an accommodation to submit a resume for positions at Lilly, please submit a accommodation request form via the Lilly workspace accommodation portal for assistance.