Apprentice - Regulatory Affairs at Eli Lilly and Company

Mexico City, Mexico City, Mexico

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Not SpecifiedCompensation

InternshipExperience Level

Part TimeJob Type

UnknownVisa

Pharmaceuticals, HealthcareIndustries

Requirements

Student of bachelor’s degree or equivalent in a relevant scientific subject (or partial completion of a relevant degree for a training position)
Good communication skills
Demonstrated good computer/IT skills
Good knowledge of written and spoken English

Responsibilities

Collaborate with the implementation of the Regulatory Plan in alignment with specific project plans as well as with regulatory requirements
Support submission of high-quality regulatory applications within planned timelines
Support Dossier assembly in compliance with local regulations and quality system requirements
Keep internal Regulatory IT tools up to date and accurate
Keep the regulatory archive complete and up-to-date and ensure that all current licenses and labels are affected by the project
Support implementation of local quality system in line with the global quality system and local regulations
Raise awareness on compliance issues with leadership and relevant functions
Ensure that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or MOH timelines
Follow global labelling procedures and document relevant exceptions to produce accurate and high-quality Product Information which is following global core labeling
Provide support for product label implementations and ensure that IT tools up to date and accurate
Support implementation of relevant internal regulatory initiatives
Execute operational aspects of regulatory affairs for a specific project, including license variation activities (e.g., labelling changes, CMC changes)
Track regulatory procedures and archive correspondence in accordance with local regulations and quality system requirements
Provide operational excellence to successfully achieve Affiliate regulatory objectives
Facilitate and cultivate relationships with relevant external regulatory personnel

Skills

Key technologies and capabilities for this role

Regulatory AffairsLicense VariationLabelling ChangesCMC ChangesRegulatory ComplianceDossier AssemblyRegulatory IT ToolsProduct InformationQuality Systems

Questions & Answers

Common questions about this position

Is this a full-time or part-time position?

This is a part-time position.

What are the minimum qualifications for the Regulatory Affairs Apprentice role?

Candidates must be students of a bachelor’s degree or equivalent in a relevant scientific subject (or partial completion for a training position), with good communication skills, demonstrated good computer/IT skills, and good knowledge of written and spoken English.

What additional skills are preferred for this apprentice position?

Preferred skills include ability to adapt to difficult challenges, team working skills with focus on results, time management skills, good capability to establish positive networking internally and externally, and knowledge of regulatory processes.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people, puts people first, and seeks determined individuals who give their best effort while contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for this Regulatory Affairs Apprentice role?

Strong candidates are current students in relevant scientific fields with solid communication, IT skills, English proficiency, adaptability, team collaboration, time management, and networking abilities to support regulatory operations effectively.

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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