Vice President, Head of Regulatory Legal

United States

Auto‑apply with AI Apply

Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates must hold a Juris Doctor (JD) degree from an accredited law school and possess a minimum of 10 years of experience in the pharmaceutical industry, with a strong preference for in-house experience. They should have a proven track record of developing and implementing effective regulatory strategies, along with a strong understanding of global regulatory frameworks and compliance requirements. Excellent written and verbal communication skills, and the ability to handle confidential information are also required.

Responsibilities

As the Vice President, Head of Regulatory Legal, the individual will be responsible for understanding regulatory implications and decisions across the biopharmaceutical lifecycle, monitoring and analyzing regulatory developments globally, maintaining relationships with regulatory authorities, leading and managing the global Regulatory Legal team, developing regulatory strategies aligned with business objectives, advising senior management on regulatory risks, overseeing the preparation and submission of regulatory documents, and ensuring company operations comply with relevant laws and regulations. They will also collaborate with cross-functional teams and oversee regulatory law advice in areas such as manufacturing, supply chain, and pharmacovigilance.

Skills

Regulatory Law

Biopharmaceutical Industry

FDA Regulations

Regulatory Submissions

Legal Strategy

Regulatory Compliance

Clinical Development

Manufacturing Law

Pharmacovigilance

Global Regulatory Affairs

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.

Land your dream remote job 3x faster with AI

Try Jobo Free