Senior Director - Counsel, Manufacturing/Supply

United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, PharmaceuticalsIndustries

Requirements

Candidates must possess a Bachelor's and Juris Doctorate (or equivalent) degree and be licensed to practice law. A minimum of 5-10 years of overall experience in a law firm or as an in-house lawyer within a medical device or pharmaceutical company is required. Qualified applicants must be authorized to work in the United States full-time, as Lilly will not provide sponsorship for work authorization or visas. Prior regulatory agency experience, some fluency/technical proficiency in manufacturing, demonstrated leadership and effectiveness working with senior leadership, and the ability to triage, prioritize, and counsel on a high volume of inputs are preferred.

Responsibilities

The Senior Director - Counsel, Manufacturing/Supply will provide legal advice on regulations and strategy for drug manufacturing and supply in the U.S. and abroad, collaborating with internal legal teams, product teams, business affiliates, and outside counsel. Responsibilities include ensuring manufacturing and quality practices align with current interpretations of laws and regulations, staying updated on manufacturing inspections and good manufacturing practices, providing legal support for global regulatory inspections, counseling on supply chain matters such as distribution and recalls, drafting and negotiating quality agreements, advising on controlled substances, influencing policy initiatives, and liaising with international business units and legal teams.

Skills

Regulatory Law

Drug Manufacturing

Supply Chain

Legal Advice

Collaboration

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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