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

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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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

Key Responsibilities

• Deep technical knowledge of biologics 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.

Basic Qualifications/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 biologics. Those with greater than ten years of experience are encouraged to apply.

Additional Skills/Preferences

• 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 biologics drug substance and/or drug product development, commercialization, or manufacturing.

• Demonstrated deep knowledge of the biologics 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.

Additional Information

• Position Location: Indianapolis, IN. This is not a remote position. Relocation assistance is provided.

• Travel: minimal within the US

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$148,500 - $257,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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