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. This role leads complex global lifecycle regulatory strategies across products and manufacturing sites, enabling high-quality, timely execution of post-approval changes while improving submission efficiency and simplifying regulatory processes.
This is accomplished with a strong working knowledge of global regulations, guidelines, and regulatory precedence, coupled with a strong technical knowledge of development, technology transfers and manufacturing processes. The Director develops collegial and mutually productive relationships with regulatory peers, across Lilly components, partner company components, and global regulatory agency personnel - partnering closely with sites and cross-functional teams to ensure high-quality, timely execution of post-approval regulatory activities.
Key Responsibilities- Deep technical knowledge and understanding of CMC molecule drug development and manufacturing science(s); broad technical knowledge of global CMC regulatory requirements and guidelines for reporting post-approval changes and updating global product registrations.
- Provide high-quality, timely, and decisive regulatory advice to allow project teams to make well-informed decisions on product lifecycle planning; anticipate and resolve technical or operational issues that could impact submission timing.
- Serve as regulatory lead for site additions and technology transfers, managing regulatory relationships with Lilly sites and external contract manufacturing organizations (CMOs) to ensure alignment on data packages and submission timelines.
- Develop and implement post-approval regulatory strategies for assigned products and sites, defining filing approaches and data expectations for site changes, analytical updates, specification changes, site additions, and related lifecycle activities.
- Lead preparation, review, and execution of variations, supplements, annual reports, DMFs, and related submissions; review and approve CMC documents for global submissions, including manufacturing changes, annual reports, and renewals.
- Lead regulatory assessments for change controls and deviations for assigned products/sites, applying risk-based principles to categorize and prioritize post-approval changes.
- Work closely with Manufacturing and Quality to develop compliant and scientifically sound data packages; coordinate with sites to ensure readiness and alignment on regulatory expectations and timelines.
- Monitor emerging regulatory guidance related to lifecycle management and apply it strategically to current and future submissions; identify opportunities to simplify lifecycle processes or accelerate submissions.
- Network with GRA, M&Q, and Business Unit leadership, as appropriate, to build awareness and alignment on complex CMC regulatory strategies; serve as a regulatory point of contact for assigned manufacturing sites.
- Contribute to implementation of digital tools supporting lifecycle management, including automated templates, digital submissions, and AI/ML applications. Experience or interest in digital enablement and process simplification is especially valued in this role.
- Communicate lifecycle strategies, risks, and timelines clearly to sites and cross-functional partners; translate regulatory implications for operational and business stakeholders.
- Supervision and/or mentoring of global regulatory affairs scientists, regulatory associates and teams as needed.
Basic Qualifications/Requirements- B.S. degree in a STEM field.
- 7 + years of Regulatory CMC or technical CMC experience supporting post-approval lifecycle management of biologics, parenteral products, combination products, or related complex modalities.
Additional Skills/Preferences- Advanced degree (MSc, PharmD, or PhD) in chemistry, biology, biochemistry, pharmacy, or a related scientific discipline preferred.
- Candidates with broader CMC lifecycle experience across modalities are encouraged to apply.
- 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 application or post-approval change processes including response 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 experience across CMC modalities relevant to Lilly's commercial portfolio (e.g., biologics, synthetic peptides, combination products, or other complex modalities), including drug substance, drug product, and analytical sciences considerations.
- Experience with aseptic/sterile manufacturing processes, container closure integrity, and sterility assurance for parenteral drug products.
- Extensive regulatory experience managing complex submission strategies, or equivalent combination of technical and regulatory expertise.
- Experience planning for and participating in Health Authority interactions.
- Demonstrated ability to assess and manage risk in a highly regulated and evolving lifecycle environment.
- Strong written, verbal, and presentation communication skills.
- Demonstrated leadership, with strong influencing and negotiation skills.
- High attention to detail and commitment to quality.
- Strong collaboration skills, with the ability to work effectively across diverse, cross-functional teams and multiple sites or CMOs.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$177,000 - $281,600
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 to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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