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

BioSpace; Indianapolis (IN); On-site; USD 101,000 - 149,000; Full time

Job summary

A leading global healthcare company is seeking a Sr. Principal Scientist/Advisor in Global Regulatory Affairs to manage post-approval regulatory CMC strategies. This role involves leveraging technical knowledge to ensure compliance and support product lifecycle management, making impactful decisions across multiple geographies.

Benefits

401(k) plan

Health insurance

Paid time off

Well-being programs

Qualifications

• 3-5 years of regulatory CMC experience or 7 years technical experience.
• Fully bilingual in English and Spanish is preferred.

Responsibilities

• Develop and evaluate global CMC regulatory strategies.
• Manage challenging projects independently, offering creative solutions.
• Provide regulatory guidance for informed decision-making.

Skills

Regulatory CMC experience

Technical knowledge of drug development

Communication skills

Leadership skills

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

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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 worldwide to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We prioritize our efforts and put people first. We’re seeking dedicated individuals committed to improving lives globally.

Lilly creates medicines that give hope—helping people get better, feel better, and live better. We are looking for post-approval regulatory CMC scientists to join us in delivering essential medicines globally.

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

Key Responsibilities

• Deep knowledge of solid oral product CMC science and manufacturing processes.
• Understanding of global CMC regulatory requirements for post-approval changes and global registration updates.
• Develop and evaluate global CMC regulatory strategies collaboratively with regulatory, manufacturing, quality, and project teams to meet submission milestones.
• Update strategies based on global regulatory changes.
• Provide regulatory guidance for informed decision-making on product lifecycle and registration.
• Anticipate and resolve technical or operational issues affecting submissions or product lifecycle.
• Manage challenging projects independently, offering creative solutions.
• Critically review CMC development strategies and submission content for registration and post-approval activities.
• Make regulatory strategy decisions impacting multiple geographies and ensure team alignment.
• Engage in site-specific regulatory activities to maintain registered commitments at manufacturing sites.

Basic Qualifications/Requirements

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

Additional Skills/Preferences

• Fully bilingual in English and Spanish.
• Deep technical knowledge of small molecule drug development, commercialization, and manufacturing.
• Experience supporting regulatory submissions for small molecules, with a mix of technical and regulatory expertise.
• Knowledge of global regulatory procedures, regulations, and evolving initiatives.
• Experience with Health Authority meetings.
• Ability to assess and manage risks in a regulated environment.
• Strong communication, leadership, negotiation, and influence skills.
• Attention to detail and effective teamwork skills.
• Strong compliance mindset and sound judgment.

Additional Information

• Location: Puerto Rico (remote not available).
• Travel: Minimal within the US.
• Salary: $101,250 - $148,500, commensurate with experience.

We are committed to a drug-free workplace and equal opportunity employment, supporting individuals with disabilities and fostering diverse employee resource groups. Compensation includes benefits such as 401(k), pension, health insurance, flexible spending, life insurance, paid time off, and well-being programs. Actual compensation depends on education, experience, skills, and location.