Senior Advisor/Director, Global Regulatory Affairs – CMC, Pre-approval, Small Molecules at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

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

Responsibilities

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
Leverage innovative regulatory strategies that can accelerate the development of assigned product(s)
Maintain deep technical knowledge of synthetic molecule CMC drug development science(s)
Maintain knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations
Develop 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
Lead preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questions
Take a proactive leadership role in the critical review of molecule specific CMC development strategies and submission content
Make decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members

Skills

CMC

Regulatory Affairs

Small Molecules

Peptides

Oligonucleotides

Clinical Trials

Marketing Authorizations

Regulatory Strategy

Synthetic Chemistry

Global Regulations

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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