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.

At Eli Lilly, we create medicines that give people new hope – to get better, feel better, live better.  It’s our purpose to create medicines that make life better for people around the world.  Lilly is looking for regulatory Chemistry, Manufacturing and Control (CMC) scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world.

We are seeking Regulatory Scientist GRACMC-Biotechnology to be a part of the Lilly global pre-approval regulatory group to support global submissions and registrations.  As the project leader, you will be expected to collaborate with the broader CMC team to provide strategic, tactical, and operational support for clinical trial applications, market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs – CMC Biotechnology will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the bioproduct portfolio. The regulatory scientist will be expected to develop and implement innovative regulatory strategies to advance the development of assigned product(s).

Key responsibilities / expectations:

Deep technical knowledge of CMC drug development science(s)Knowledge of bioproduct CMC global regulatory requirements and guidelines for conducting clinical trials and obtaining global product marketing registrationsDevelopment of regulatory strategy to ensure alignment with current and evolving global regulatory expectationsProvide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planningLeads preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questionsTakes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission contentMakes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members

Minimum Requirements:

B.S. degree in a science, engineering, or a related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar)Minimum of 7 years of Bioproduct Regulatory CMC experience supporting clinical phases of development and/or commercialization, experience should include authoring CMC submission content, and involvement in clinical trial and commercial processes including response to questions

Preferred Experiences and Skills:

Less experience with advance degree would be consideredExperience in biotechnology drug substance and/or drug product development, commercialization, or manufacturingDemonstrated deep knowledge of the biologic drug development process. Knowledge in new molecular modalities (e.g., oligonucleotides, cell and gene therapy) preferred but not required.Experience planning for and participating in Health Authority meetingsKnowledge of major market procedures, regulations and practices. Awareness of evolving regulatory initiatives desirable.Demonstrated ability to assess and manage risk in a highly regulated environment.Demonstrated strong written, verbal and presentation communication skills.Demonstrated leadership behaviors and negotiation and influence skills.Demonstrated attention to detailDemonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Additional Information:

Position Location:  IndianapolisTravel:  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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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