Lilly Advisor/Sr. Advisor - Global Regulatory Affairs - CMC - Small Molecules in Indianapolis, Indiana
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 CMC scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world.
The Advisor in Global Regulatory Affairs – CMC Small Molecules 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 small molecule portfolio. The regulatory scientist will be expected to leverage innovative regulatory strategies that can accelerate the development of assigned product(s).
Deep technical knowledge of CMC drug development science(s)
Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations
Development of regulatory strategy and update strategy based upon global regulatory changes
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 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 field (advanced degree preferred). Fields of study include Chemistry, Pharmaceutics, Chemical Engineering, Analytical Sciences, Biology, or similar.
Five years of Regulatory CMC experience supporting clinical phases of development and/or commercialization
Experience authoring CMC submission content, and involvement in CTA/MAA processes including response to questions.
Knowledge of major market procedures, regulations and practices. Awareness of evolving regulatory initiatives desirable.
Relevant experience in small molecule drug substance and/or drug product development, commercialization, or manufacturing.
Demonstrated deep knowledge of the small molecule drug development process. Knowledge in new molecular modalities (e.g., oligonucleotides, synthetic peptides) or new manufacturing technologies (e.g., continuous manufacturing) preferred but not required.
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.
Remote working is available for this role
Travel requirements: 0 – 10%.
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 ( LillyRecruitingCompliance@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.
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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).