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 35,000 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 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 Research 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).

Responsibilities:

• 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 registrations




• Development of regulatory strategy to ensure alignment with current and evolving global regulatory expectations




• Provide regulatory guidance to allow CMC development teams to make well-informed decisions on development or product lifecycle planning




• Leads preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questions




• Takes a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content




• Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members

Basic Requirements:

• B.S. degree in a science, engineering, or a related field (Chemistry, Biology, Biochemistry, Pharmaceutics, Engineering, Analytical Sciences, or similar)




• Five 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

Additional preferences and Skills:

• Experience in biotechnology drug substance and/or drug product development, commercialization, or manufacturing




• Advanced degree preferred




• Demonstrated 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 meetings




• Knowledge 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 detail




• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.

Additional Information:

• Position Location:  Indianapolis OR remote option available




• Travel:  minimal within the US

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.