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Senior Advisor/Director, Global Regulatory Affairs – CMC

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Feb 7, 2024

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Discipline
Regulatory, Regulatory Affairs, Science/R&D, CMC
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

Job Details

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 Control (CMC) scientists to join us in developing and bringing life-changing new medicines to patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs – CMC 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 synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides. The regulatory scientist will be expected to leverage innovative regulatory strategies that can accelerate the development of assigned product(s).

Key responsibilities:

  • Deep technical knowledge of synthetic molecule 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.
  • Minimum of five years of Regulatory CMC experience supporting clinical phases of development and/or commercialization of synthetic molecules. Those with greater than five years experience are encouraged to apply.

Additional Skills/Preferences

  • 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 synthetic molecule drug substance and/or drug product development, commercialization, or manufacturing.
  • Demonstrated deep knowledge of the synthetic 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.
  • 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 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.

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.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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