Lifecycle Regulatory Scientist, CMC & Post‑Approval

Eli Lilly and Company; Carolina (PR); On-site; USD 84,000 - 154,000; Full time

Benefits offered by this job

401(k) plan

Pension benefits

Generous vacation

Well-being programs

Job summary

Lilly is seeking a Regulatory Scientist in the Lifecycle Innovation group to drive post-approval CMC regulatory strategies across its global portfolio. The role partners with senior colleagues to expedite submissions and support lifecycle management of Lilly products.

Responsibilities include preparing CMC content, coordinating with manufacturing sites, and advancing digital tools for submissions, while ensuring alignment with regulatory expectations across geographies.

Qualifications

• College degree in biological/pharmaceutical/life sciences.
• Regulatory affairs experience in pharma/biotech.
• Understanding of global CMC regulations and lifecycle principles.
• Experience with change control and deviation assessments.

Responsibilities

• Provide regulatory and scientific expertise for solid oral products.
• Collaborate with regulatory scientists and directors on outsourcing and CMOs.
• Prepare CMC dossiers and variation packages for submissions.
• Develop regulatory strategies and coordinate with cross-functional teams.

Skills

Regulatory affairs

Global CMC knowledge

Post-approval experience

Change control experience

GMP knowledge

Communication skills

RIM proficiency

MS Office

Education

Bachelor's degree in life sciences

Tools

RIM

MS Office

Job description

Lilly is seeking a Regulatory Scientist in the Lifecycle Innovation group to drive post-approval CMC regulatory strategies across its global portfolio. The role partners with senior colleagues to expedite submissions and support lifecycle management of Lilly products.

Responsibilities include preparing CMC content, coordinating with manufacturing sites, and advancing digital tools for submissions, while ensuring alignment with regulatory expectations across geographies.