Director, Global Regulatory Affairs – CMC, Lifecycle Innovation
About the role
withcontaining that paragraph(s). Should we split? Probably one paragraph. Then "Key Responsibilities" list: many bullet-like sentences separated by semicolons? Actually they are sentences separated by semicolons and periods. We need to extract each duty as list items. The text after "Key Responsibilities" includes a long paragraph with many items separated by semicolons and periods. We need to break into list items. We'll need to parse manually. Let's extract 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." "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." That's responsibilities. Now "Basic Qualifications/Requirements" section: includes bullet-like items separated by periods. "B.S. degree in a STEM field." "10+ years of Regulatory CMC or technical CMC experience supporting post-approval lifecycle management of biologics, parenteral products, combination products, or related complex modalities." That's basic qualifications. Then "Additional Skills/Preferences": list many items. "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." Now Additional Information includes location, travel, relocation assistance, EEO, ERGs, compensation, benefits. We need sections: Benefits, Pay, Schedule. Also maybe "Qualifications" vs "Requirements". The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to map content. We have Basic Qualifications/Requirements -> could be "Requirements". Additional Skills/Preferences -> could be "Skills" or "Qualifications". The instruction says we can have both Requirements and Qualifications sections. We'll put basic qualifications under "Requirements". Additional skills/preferences under "Skills". Possibly also "Qualifications" for advanced degree? But we can treat Advanced degree as part of Skills or Qualifications. Let's follow: Requirements = basic qualifications. Skills = additional skills/preferences. Qualifications maybe not needed if we already have Requirements and Skills. But we could put advanced degree under Qualifications. However instruction: Prefer a few substantive sections over many thin ones. So maybe combine Requirements and Qualifications? But they said we can use those headings. We'll decide: We'll have Requirements (basic), Qualifications (advanced degree preferred), Skills (the rest). That yields three sections. Now Benefits: The posting mentions: "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)." Also mentions relocation assistance provided. Also mentions company bonus. Also mentions travel minimal within US. Also mentions relocation assistance is provided. Also mentions "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)." So Pay section: salary range and bonus. Schedule: Not explicitly mentioned besides "Full-time equivalent employees". Could infer full-time. But we should not create Schedule unless posting actually states them. It does not state schedule like "Monday-Friday, 9-5". It only says full-time equivalent employees. That's not a schedule detail. So we should not create Schedule section. Benefits: we have details. Also relocation assistance is a benefit. We'll include that. Now About the role: include the introductory paragraph(s) before "The Director, GRA-CMCD Lifecycle Innovation provides scientific..." Actually that is also part of role description. Might be better to put that as About the role. We'll include the first paragraph(s) up to "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." That's about Lilly and role invitation. Then the role description starts with "The Director, GRA-CMCD Lifecycle Innovation provides scientific..." That could be part of About the role as well, but we already have Responsibilities separate. Usually About the role includes summary of role. We'll include that sentence as part of About the role. Thus About the role: combine the initial mission paragraph and the role summary sentence. Let's craft:
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 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.
Now Responsibilities: list items as- each. We need to ensure we preserve all substantive information. We'll break each responsibility as separate
- . Use the sentences we identified. Let's list them: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. 6. Lead regulatory assessments for change controls and deviations for assigned products/sites, applying risk-based principles to categorize and prioritize post-approval changes. 7. 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. 8. 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. 9. 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. 10. Contribute to implementation of digital tools supporting lifecycle management, including automated templates, digital submissions, and AI/ML applications. 11. Communicate lifecycle strategies, risks, and timelines clearly to sites and cross-functional partners; translate regulatory implications for operational and business stakeholders. 12. Supervision and/or mentoring of global regulatory affairs scientists, regulatory associates and teams as needed. Now Requirements (basic qualifications): - B.S. degree in a STEM field. - 10+ years of Regulatory CMC or technical CMC experience supporting post-approval lifecycle management of biologics, parenteral products, combination products, or related complex modalities. Now Qualifications (advanced degree preferred): - Advanced degree (MSc, PharmD, or PhD) in chemistry, biology, biochemistry, pharmacy, or a related scientific discipline preferred. Now Skills (additional skills/preferences): List each bullet. - Candidates with broader CMC lifecycle experience across modalities are encouraged to apply. - Experience developing regulatory