Associate Vice President, Assistant General Counsel, Regulatory Legal Team, International – Americas Region at Eli Lilly and Company

Indianapolis, Indiana, United States

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$225,000 – $330,000Compensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, BiotechnologyIndustries

Requirements

Bachelor’s and Juris Doctorate (or equivalent) Degrees
Licensed to practice law
Demonstrated expertise in the law and regulations pertaining to pharmaceuticals, medical devices and diagnostics in Brazil, Mexico, Colombia and other key markets in the Americas Region
Minimum of 5-7 years’ experience as a lawyer in a law firm, or as an in-house lawyer in a pharmaceutical company, where candidate’s primary focus was pharmaceutical law
Minimum 7-10 years of overall experience in a law firm or as an in-house lawyer in a device or pharmaceutical company
Qualified candidates must be legally authorized to be employed in their country of residence

Responsibilities

Provide legal advice regarding regulations and strategy on drug, medical device (software and hardware) and diagnostic matters for the Americas Region (primarily South and Central America and other jurisdictions)
Leverage advice through collaboration with Lilly lawyers who work directly with product teams and business affiliates as well as outside counsel as required
Provide legal counsel on matters related to drug, medical device and diagnostic clinical programs and regulatory submissions
Provide legal counsel that ensures Lilly clinical development programs incorporate the latest and cutting-edge interpretations of applicable laws, regulations, guidance, and harmonized standards
Stay current on the latest drug, medical device and diagnostics laws, regulations and guidance documents, including recently passed or implemented and emerging laws and regulations
Influence internal and external stakeholders regarding key policy initiatives including participation at select trade association meetings and other external activities
Provide legal support to the Global Regulatory Strategy Teams and Americas Regional Regulatory Team and related policy groups regarding Americas Region policy and legislative issues related to drugs, medical devices and diagnostics
Maintain and improve an understanding of the clinical and regulatory submissions process and regulatory structures in Americas Region countries
Liaise and partner with International Business Unit representatives and legal teams to ensure appropriate connections are in place to facilitate one-voice counseling

Skills

Key technologies and capabilities for this role

Regulatory LawDrug RegulationsMedical Device LawDiagnostic RegulationsClinical DevelopmentRegulatory SubmissionsFDA ComplianceLegal CounselCross-Functional CollaborationSouth America RegulationsCentral America RegulationsGlobal Regulatory Affairs

Questions & Answers

Common questions about this position

What is the anticipated salary range for this position?

The anticipated wage for this position is $225,000 - $330,000, and actual compensation will depend on a candidate’s education, experience, skills, and geographic location.

Is this a remote position or does it require working from a specific location?

This information is not specified in the job description.

What key skills or expertise are required for this role?

The role requires expertise in regulations and strategy on drug, medical device (software and hardware), and diagnostic matters, knowledge of clinical development programs and regulatory submissions, and the ability to stay current on laws, regulations, and guidance in the Americas Region.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, and encourages giving back to communities through philanthropy and volunteerism while seeking determined individuals.

What makes a strong candidate for this Associate Vice President role?

Strong candidates will have education, experience, and skills in regulatory legal matters for drugs, medical devices, and diagnostics in the Americas Region, with the ability to collaborate cross-functionally, stay current on regulations, and influence stakeholders.

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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