Director, Global Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC), Platform Innovation - Small Molecules

Eli Lilly and Company•Indianapolis, IN

1d•Onsite

About The Position

This role provides strategic, tactical and operational regulatory CMC leadership across therapeutic modalities and manufacturing technologies to expedite development of the small molecule portfolio and to support clinical trial applications, market registrations, and post approval submissions. This is accomplished through a strong working knowledge of global regulations, guidelines, and regulatory precedent coupled with deep technical knowledge of CMC development and manufacturing processes.

Requirements

B.S. degree in a science, engineering, or a related STEM field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
10+ years of Regulatory CMC or technical CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules.
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.

Nice To Haves

advanced degree preferred

Responsibilities

Deep technical knowledge of small molecule CMC drug development and manufacturing sciences across modalities and platforms (drug substance, drug product, analytical sciences).
Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations and maintaining approved registrations.
Development and implementation of innovative regulatory strategies and platform approaches based on changes in external environment (new guidance, evolving expectations, and regulatory precedent).
Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning.
Leads preparation, critical review, and approval of CMC documents for global regulatory submissions and responses, including clinical trial applications, marketing applications, variations/supplements, and health authority information requests.
Takes a proactive leadership role in the critical review of molecule specific CMC development and lifecycle strategies.
Provides high quality, timely and clear regulatory advice to allow project teams to make well-informed decisions on development or product lifecycle planning.
Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.

Benefits

Relocation assistance is provided.
company bonus (depending, in part, on company and individual performance).
company-sponsored 401(k)
pension
vacation benefits
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
well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).