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

Key technologies and capabilities for this role

Regulatory AffairsGlobal LabelingLabel DevelopmentDrug ProductsCombination DevicesCore Labeling Oversight

Questions & Answers

Common questions about this position

What benefits does Eli Lilly offer?

Lilly offers flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, on-site parking, Inhouse People Development services, Educational Assistance, and ‘Live Your BEST Life’ wellbeing initiatives.

Is this a remote position, or is there an office requirement?

The role is based at Eli Lilly Cork with a premium workspace across the campus in Little Island and includes flexible hybrid working options.

What are the main responsibilities of this role?

The role involves leading the development and maintenance of global core labeling (Core Data Sheet, Core Device Labeling, and CMC Core Labeling Content), facilitating approval by committees, providing oversight of global implementation, and serving as the primary interface with the Printing Packaging Development organization for US and Canada labeling.

What is the company culture like at Eli Lilly Cork?

Eli Lilly Cork features a talented diverse team of over 1,400 employees across 38 nationalities, encourages being creative, an innovator, and yourself, and emphasizes putting people first while uniting caring with discovery.

What is the employment duration for this position?

This is a 12 month Fixed Term Contract (FTC).

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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