Associate / Sr Associate - Regulatory Labeling at Eli Lilly and Company

Cork, County Cork, Ireland

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Demonstrate in-depth understanding of content, format, and style requirements for labeling documents including local regulations, guidance, and trends

Responsibilities

Lead the development and maintenance of Core labeling [i.e., Core Data Sheet (CDS), Core Device Labeling (CDL), and CMC Core Labeling Content]
Lead the preparation activities and facilitate approval of Core labeling by the Global Product Labeling Committee for CDS and CDL and Global Labeling Council for CMC CLC
Communicate initial and revised Core labeling to global affiliates and provide support and consultation, as necessary
Lead the development and maintenance of US and Canada packaging for Lilly drug and combination device products
Lead the development and maintenance of US and Canada combination product patient labeling [i.e., Instructions for Use (IFU) and Quick Reference Guide (QRG)]
Serve as primary liaison with the Device Delivery & Connected Solutions (DDCS) organization
Lead the development and maintenance of Clinical Trial IFUs
Conduct data integrity reviews of healthcare provider labeling in partnership with Regional Regulatory
Serve as primary liaison with PPD organization for implementation of US and Canada labeling
Serve as primary liaison with DDCS and PPD organizations

Skills

Regulatory Affairs

Global Labeling

Label Development

Drug Products

Combination Devices

Core Labeling Oversight

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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