Director, Global Regulatory Affairs – Chemistry, Manufacturing and Controls (CMC), Platform Innovation – Synthetic Peptides and Oligonucleotides

Lilly • Indianapolis, IN

3d • $177,000 - $308,000

About The Position

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. The position supports clinical trial applications, market registrations, and post-approval submissions through global regulatory knowledge and deep technical expertise in CMC development and manufacturing processes specific to synthetic peptides and oligonucleotides.

Requirements

• B.S. degree in a science, engineering, or related STEM field.
• 10+ years of Regulatory CMC or technical CMC experience supporting clinical development and/or commercialization of synthetic peptides, oligonucleotides, or related complex modalities.
• 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 effectively across diverse, cross-functional teams.

Nice To Haves

• Advanced degree in a relevant field.
• Experience authoring CMC submission content for peptides and/or oligonucleotides, including 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.
• Understanding of development considerations for peptides and oligonucleotides, including 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 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 modality space.
• Broader experience in advanced modalities.

Responsibilities

• Apply 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.
• Apply knowledge of global CMC regulatory requirements and guidelines to support clinical development, global product registrations, and lifecycle management of approved products.
• Develop and implement innovative regulatory strategies and platform-based approaches that incorporate evolving external expectations.
• Provide regulatory guidance to help CMC development teams make 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 or supplements, and health authority queries.
• Proactively review molecule-specific CMC development and lifecycle strategies, including considerations unique to peptides and oligonucleotides.
• Provide timely and clear regulatory advice to project teams advancing complex modalities.
• Make decisions on CMC regulatory strategies affecting global submissions and ensure alignment across geographies, teams, and platform approaches.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k) and pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, such as 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.
• Employee resource groups open to all employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Director