Sr. Principal Scientist/ Advisor Global Regulatory Affairs – CMCD, Lifecycle Innovation for Solid Oral Products

Eli Lilly and Company • Carolina, PR

1d • $105,000 - $154,000

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Patients are at the center of everything we do at Lilly. We are currently hiring a Sr. Principal Scientist. This role supports critical work that helps bring medicines and solutions to patients responsibly and efficiently. #WeAreLilly Purpose: The Lifecycle Innovation group in GRA‑CMCD is responsible for ensuring Eli Lilly and Company develops and executes effective post‑approval CMC regulatory strategies across its global commercial portfolio. The group drives lifecycle regulatory excellence by supporting manufacturing sites, enabling process simplification, accelerating submission efficiency, and applying innovative digital and regulatory approaches to post‑approval change management. The purpose of the Sr. Principal Scientist/Advisor/Sr. Advisor role is to provide strategic, tactical, and operational direction in support of Lilly’s marketed portfolio by developing successful regulatory strategies and submissions globally. To accomplish this, the scientist develops collegial and mutually productive relationships with CMC customers, including personnel within pharmaceutical manufacturing sites (e.g., Manufacturing Science and Technology, Quality Assurance, Production, Supply Chain), bulk manufacturing sites, and contract manufacturers whose material is used in Lilly products. The scientist utilises CMC technical knowledge, regulatory expertise, and lessons learned across GRA‑CMCD to drive internal consistency, influence effective change management, and contribute to lifecycle innovation and continuous improvement initiatives.

Requirements

• BSc, MSc, PharmD, or PhD in Chemistry, Pharmacy, Biology, Biochemistry, or related scientific discipline, or Bachelor’s with equivalent experience.
• Pharmaceutical industry experience in a manufacturing environment, e.g., Manufacturing Sciences and Technology, Quality Assurance, Analytical Laboratories, or Manufacturing (7–10 years).
• Prior regulatory CMC experience (3–7 years) or equivalent combination of technical and regulatory guidance knowledge.
• Strong understanding of global CMC regulations, manufacturing sciences, GMP, and lifecycle strategies.
• Experience with change control, comparability, deviation assessments, and post‑approval filings.
• Demonstrated strong interpersonal and leadership skills; ability to interact effectively within group and with customer base.
• Demonstrated ability to organize and analyze detailed information.
• Demonstrated ability to identify, drive, and support business process improvement initiatives.
• Demonstrated ability to work independently.
• Demonstrated strong written and verbal communication skills.
• Demonstrated ability to understand and apply risk analysis concepts.
• Demonstrated ability to deliver projects according to agreed‑upon timelines.
• Fully bilingual (English/Spanish)
• Excellent communication and cross‑functional collaboration skills.
• Ability to identify regulatory opportunities and support operational improvement.

Nice To Haves

• Experience with digital tools, automation, or AI/ML applications is a plus.
• Ability to work across multiple sites or with CMOs.
• Demonstrated ability to support change initiatives and drive adoption of new practices.
• Ability to collaborate effectively with site teams and influence cross‑functional partners

Responsibilities

• Regulatory & Scientific Expertise
• Influence, Innovation & Digital Enablement
• Lead / Partner & Site Engagement

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees