Regulatory CMC Leader at Lilly

Compensation

$148,500 – $257,400/yr

Setup: Remote
Location: Indianapolis, Indiana
Type: Full-time
Level: Lead

Description

This role involves providing strategic, tactical, and operational regulatory CMC leadership to accelerate the development of small molecule portfolios and support various regulatory submissions like clinical trial applications and market registrations. It requires extensive knowledge of global regulations, guidelines, and regulatory precedents, along with deep technical expertise in CMC development and manufacturing processes.

Required Skills

Small Molecule Drug Development
Global CMC Regulations
Innovative Regulatory Strategies
Authoring CMC Submissions
Clinical Trial Applications
Synthetic Molecule Development
Risk Assessment
Communication Skills
Leadership Negotiation
Teamwork Skills

Additional Information

Required Previous Experiences: 10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules.
Preferred Qualifications: Experience authoring CMC submission content, and involvement in clinical trial applications/marketing authorization application processes including response to questions.
Knowledge of major market procedures, regulations, and practices. Awareness of evolving regulatory initiatives.
Relevant experience in synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.
Demonstrated deep knowledge of the synthetic molecule drug development process.
Extensive prior regulatory experience handling complex regulatory submission strategies or equivalent combination of technical and regulatory guidance knowledge and experience.
Experience planning for and participating in Health Authority meetings.
Demonstrated ability to assess and manage risk in a highly regulated environment.
Demonstrated strong written, spoken and presentation communication skills.
Demonstrated leadership behaviors and negotiation and influence skills.
Demonstrated attention to detail.
Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.