[Remote] Associate Vice President, Assistant General Counsel, Regulatory Legal Team, International – Asia Pacific Region at Eli Lilly and Company

Amissville, Virginia, United States

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Not SpecifiedCompensation

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 China, Japan and other key markets in the Asia-Pacific 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 Asia-Pacific Region (China, Japan, Korea, Australia, Taiwan and other jurisdictions), leveraging advice through collaboration with Lilly lawyers, product teams, business affiliates, and 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 Asia-Pacific Regional Regulatory Team and related policy groups regarding Asia-Pacific country 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 Asia-Pacific 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 SubmissionsChina RegulationsJapan RegulationsKorea RegulationsAustralia RegulationsTaiwan RegulationsGlobal Regulatory Affairs

Questions & Answers

Common questions about this position

What are the basic educational and professional requirements for this role?

Candidates must have a Bachelor’s and Juris Doctorate (or equivalent) Degrees and be licensed to practice law, along with demonstrated expertise in the law and regulations.

What is the primary geographic focus of this position?

The role focuses on providing legal advice for the Asia-Pacific Region, including China, Japan, Korea, Australia, Taiwan, and other jurisdictions.

What kind of legal expertise is needed for this job?

Expertise in drug, medical device (software and hardware), and diagnostic regulations, particularly for clinical programs, regulatory submissions, and staying current on laws in the Asia-Pacific region.

What is the team structure for this position?

This position is part of the Regulatory Legal Team (RLT), which reports up through Lilly’s General Counsel and works across Lilly Legal and the Company with a highly cross-functional approach.

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

A strong candidate will have a JD, bar licensure, and demonstrated expertise in regulatory law for drugs, medical devices, and diagnostics, plus the ability to collaborate cross-functionally and stay current on Asia-Pacific 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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