Sr. Principal Scientist/Advisor Global Regulatory CMC-Commercial Product/Post Approval Scientist

Society for Conservation Biology; Indianapolis (IN); On-site; USD 101,000 - 149,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Sr. Principal Scientist/Advisor for Global Regulatory Affairs in Indianapolis. This role involves leveraging CMC technical knowledge to develop regulatory strategies for product lifecycle management. Ideal candidates will have a strong background in regulatory CMC and solid oral product development, along with excellent communication and leadership skills. Join us to contribute to life-changing medicines and improve patient outcomes.

Qualifications

• 3-5 years of regulatory CMC experience or 7 years of technical experience in oral solid product development.
• Fluency in English and Spanish preferred.
• Experience with Health Authority meetings.

Responsibilities

• Develop and evaluate global CMC regulatory strategies.
• Provide regulatory guidance for CMC team decisions.
• Manage challenging projects independently.

Skills

Regulatory CMC experience

Technical knowledge of solid oral product CMC science

Risk assessment

Communication

Leadership

Negotiation

Teamwork

Attention to detail

Education

Bachelor's degree or higher in science or engineering

Job description

Sr. Principal Scientist/Advisor Global Regulatory CMC-Commercial Product/Post Approval Scientist

Employer: Eli Lilly and Company | Location: Indianapolis, Indiana, US | Salary: Competitive | Closing date: May 24, 2025

Sector: Consultancy/Private Sector | Field: Conservation science | Discipline: Biology | Salary Type: Salary | Employment Type: Full time

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 work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and support our communities through philanthropy and volunteerism. We prioritize our work and put people first.

We create medicines that give people new hope—to get better, feel better, and live better. Lilly is seeking post-approval regulatory CMC scientists to join us in delivering life-changing medicines globally.

The Sr. Principal Scientist or Advisor Post Approval Scientist in Global Regulatory Affairs - CMC Commercial Products will utilize CMC technical knowledge and regulatory science expertise to develop and execute regulatory strategies, including post-approval and lifecycle submissions for Lilly's products. The role involves leveraging innovative strategies to support product lifecycle management.

Key Responsibilities:

• Deep technical knowledge of solid oral product CMC science and manufacturing processes.
• Understanding of global CMC regulatory requirements and guidelines for post-approval changes and global registration updates.
• Develop and evaluate global CMC regulatory strategies in collaboration with regulatory, manufacturing, quality, and project teams to meet submission milestones.
• Update strategies based on global regulatory changes.
• Provide regulatory guidance to inform CMC team decisions on global registrations and lifecycle planning.
• Anticipate and resolve technical or operational issues impacting submissions.
• Manage challenging projects independently, identifying creative solutions.
• Review molecule-specific CMC development strategies and submission content for registration, post-approval changes, line extensions, renewals, and responses to inquiries.

Minimum Qualifications:

• Bachelor's degree or higher in science or engineering (Chemistry, Pharmacy, Pharmaceutics, Analytical Sciences, Biology, Biochemistry, Chemical Engineering).
• 3-5 years of regulatory CMC experience or 7 years of technical experience in oral solid product development, commercialization, or manufacturing.

Preferred Skills:

• Fluency in English and Spanish.
• Deep technical knowledge of small molecule drug development, commercialization, and manufacturing.
• Experience supporting commercialization and post-approval submissions.
• Knowledge of major market regulations and evolving global initiatives.
• Experience with Health Authority meetings.
• Strong risk assessment, communication, leadership, negotiation, and teamwork skills.
• Attention to detail and sound judgment.

Additional Information:

• Location: Puerto Rico (remote not available).
• Minimal travel within the US.
• Salary depends on experience; estimated range: $101,250 - $148,500.

Note: Lilly maintains a drug-free workplace and is committed to diversity and inclusion. Accommodations are available for applicants with disabilities. Lilly is an EEO employer.