Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls at Lilly

Indianapolis, Indiana, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Sep, 26

Salary

257400.0

Posted On

27 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory CMC Leadership, Synthetic Peptides, Oligonucleotides, Global Regulatory Strategy, CMC Documentation, Drug Substance Development, Drug Product Development, Analytical Sciences, Lifecycle Management, Health Authority Interactions, Risk Management, Cross-functional Collaboration, Technical Writing, Regulatory Compliance, Platform Innovation, Strategic Planning

Industry

Pharmaceutical Manufacturing

Description

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. This role provides strategic, tactical, and operational regulatory CMC leadership across advanced therapeutic modalities and manufacturing technologies to accelerate development of the synthetic peptides and oligonucleotide portfolio, supporting clinical trial applications, market registrations, and post-approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory precedent, coupled with deep technical expertise in CMC development and manufacturing processes specific to synthetic peptides and oligonucleotides. Key Responsibilities Deep technical knowledge of synthetic peptide and oligonucleotide CMC drug development and manufacturing sciences across modalities and platforms, including drug substance, drug product, and analytical sciences (e.g., solid-phase synthesis, purification, conjugation, characterization, and control strategies). Knowledge of global CMC regulatory requirements and guidelines for synthetic peptides and oligonucleotides to support clinical development, global product registrations, and lifecycle management of approved products. Development and implementation of innovative regulatory strategies and platform-based approaches, incorporating evolving external expectations (e.g., emerging guidance, novel modality considerations, and regulatory precedent). Provide regulatory guidance enabling CMC development teams to make well-informed decisions on development strategies and lifecycle planning. Lead preparation, critical review, and approval of CMC documentation for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and responses to health authority queries. Take a proactive leadership role in the critical review of molecule-specific CMC development and lifecycle strategies, including considerations unique to peptides and oligonucleotides (e.g., impurity profiles, sequence-related variants, delivery systems, and stability). Provide high-quality, timely, and clear regulatory advice to support project teams in advancing complex modalities. Make decisions on CMC regulatory strategies impacting global submissions, ensuring alignment across geographies, teams, and platform approaches. Basic Qualifications/Requirements B.S. degree in a science, engineering, or related STEM field (advanced degree preferred), such as Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biochemistry, Molecular Biology, or similar. 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides, oligonucleotides, or related complex modalities. Candidates with broader experience in advanced modalities are encouraged to apply. Additional Skills/Preferences Experience authoring CMC submission content for peptides and/or oligonucleotides, including participation in clinical trial and marketing authorization applications and responses to regulatory questions. Knowledge of major global regulatory procedures, regulations, and evolving expectations for complex modalities, including platform technologies. Relevant experience in peptide and/or oligonucleotide drug substance and/or drug product development, manufacturing, and commercialization. Demonstrated understanding of key development considerations for peptides and oligonucleotides (e.g., synthesis scalability, impurity control, analytical characterization, stability, and delivery systems such as conjugates or lipid-based formulations). 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 modality space. 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 ability to work effectively across diverse, cross-functional teams. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL). Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $148,500 - $257,400 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. #WeAreLilly

Responsibilities

Provide strategic and operational regulatory CMC leadership for synthetic peptides and oligonucleotide portfolios to accelerate development and market registration. Lead the preparation and review of global regulatory submissions and provide technical guidance to CMC development teams.