Director, Global Regulatory Affairs – CMC, Lifecycle Innovation

Lilly • Indianapolis, IN

2d • $177,000 - $308,000

About The Position

The Director, GRA-CMCD Lifecycle Innovation provides scientific, strategic, tactical, and operational regulatory leadership for post-approval CMC activities across Lilly’s parenteral product commercial portfolio. The role leads complex global lifecycle regulatory strategies across products and manufacturing sites, supporting high-quality, timely execution of post-approval changes while improving submission efficiency and simplifying regulatory processes.

The position requires strong knowledge of global regulations, guidelines, and regulatory precedence, together with technical knowledge of development, technology transfers, and manufacturing processes. The Director builds productive relationships with regulatory peers, Lilly and partner-company teams, manufacturing sites, and global regulatory agency personnel, working closely with cross-functional partners to deliver post-approval regulatory activities.

The role also supports digital tools for lifecycle management, including automated templates, digital submissions, and AI/ML applications, and may supervise or mentor global regulatory affairs scientists, associates, and teams.

Requirements

• B.S. degree in a STEM field.
• At least 7 years of Regulatory CMC or technical CMC experience supporting post-approval lifecycle management of biologics, parenteral products, combination products, or related complex modalities.
• Experience developing regulatory strategies, determining submission data packages, authoring CMC submission content for biologic and/or parenteral products, and leading teams to deliver timely submissions.
• Experience with marketing authorization applications or post-approval change processes, including responding to questions.
• Knowledge of major global regulatory procedures, regulations, and evolving expectations for post-approval lifecycle management, including change control, comparability, deviation assessments, and post-approval filings.
• Relevant CMC experience across modalities in Lilly’s commercial portfolio, including drug substance, drug product, and analytical sciences considerations.
• Experience with aseptic or sterile manufacturing, container closure integrity, and sterility assurance for parenteral drug products.
• Extensive regulatory experience managing complex submission strategies, or an equivalent combination of technical and regulatory expertise.
• Experience planning for and participating in Health Authority interactions.
• Ability to assess and manage risk in a highly regulated and evolving lifecycle environment.
• Strong written, verbal, and presentation communication skills.
• Demonstrated leadership, influencing, and negotiation skills.
• High attention to detail and commitment to quality.
• Strong collaboration skills and ability to work across diverse cross-functional teams, multiple sites, and CMOs.

Nice To Haves

• Advanced degree (MSc, PharmD, or PhD) in chemistry, biology, biochemistry, pharmacy, or a related scientific discipline.
• Broader CMC lifecycle experience across modalities.
• Experience or interest in digital enablement and process simplification.

Responsibilities

• Provide regulatory advice and technical expertise on CMC molecule development, manufacturing science, and global requirements for post-approval changes and product registration updates.
• Advise project teams on product lifecycle planning and anticipate and resolve issues that could affect submission timing.
• Lead regulatory activities for site additions and technology transfers, coordinating with Lilly sites and external contract manufacturing organizations on data packages and timelines.
• Develop and implement post-approval regulatory strategies for assigned products and sites, including filing approaches and data expectations for site changes, analytical updates, specification changes, and other lifecycle activities.
• Lead preparation, review, and execution of variations, supplements, annual reports, DMFs, and related submissions; review and approve CMC documents for global submissions, manufacturing changes, annual reports, and renewals.
• Conduct regulatory assessments of change controls and deviations, applying risk-based principles to categorize and prioritize post-approval changes.
• Work with Manufacturing, Quality, and sites to develop compliant, scientifically sound data packages and ensure readiness and alignment on regulatory expectations and timelines.
• Monitor emerging regulatory guidance on lifecycle management and apply it to submissions; identify opportunities to simplify processes or accelerate submissions.
• Build awareness and alignment on complex CMC strategies with GRA, Manufacturing and Quality, and Business Unit leadership; serve as a regulatory contact for assigned manufacturing sites.
• Contribute to digital lifecycle-management tools and process improvements, including automated templates, digital submissions, and AI/ML applications.
• Communicate lifecycle strategies, risks, and timelines to sites and cross-functional partners, translating regulatory implications for operational and business stakeholders.
• Supervise or mentor global regulatory affairs scientists, regulatory associates, and teams as needed.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits.
• 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: Director