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Intern - Regulatory Delivery & Excellence - Global Publisher

Role overview

Qualifications

  • Currently enrolled in 3rd level education
  • Bsc or MSc in Biomedical sciences, Biopharma, Pharmaceutical, or Life Sciences
  • Knowledge of drug development process

Responsibilities

  • Create and maintain regulatory registrations from candidate selection through end of product lifecycle
  • Create global registrations and provide maintenance support as needed for major markets
  • Optimize business processes and ensure implementation of the regulatory agency’s eCTD specifications
  • Build eCTD expertise and partner with relevant stakeholders to ensure adherence to submission regulations and guidelines

Key facts

  • Remote from: Ireland
  • Internships
  • Entry-level / graduate
  • English

Hard skills

Other skills

  • Communication
  • Teamwork
  • Problem Solving

About the company

Lilly-Lilly logo

Lilly-Lilly

Alternative & Complementary Medicine

This embraces the joint ventures of Simon and Sue Lilly. Simon and Sue Lilly travel worldwide in response to requests for teaching. They have written over thirty books covering the topics commonly known as 'energy healing', which include crystal healing, colour healing, essences, astrology, runes, working with trees and tree spirits.

Company details

IndustryAlternative & Complementary Medicine
Company size2 - 10

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Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. 


Intern - Regulatory Delivery & Excellence - Global Publisher  

Positions: 1 

Start date: January 

Duration: 8 months  

Salary: €30,500  

Location: Lilly, GBS Little Island 

Type: Hybrid role requiring the successful candidate to be on site 50% of the month in Little Island, Cork and 50% working remotely. 

Course Eligibility: Bsc or MSc in Biomedical sciences,  Biopharma, Pharmaceutical, or Life Sciences 

 

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 47,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.  
 
Eli Lilly Cork is made up of a talented diverse team of over 2,000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. 

Lilly offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.  Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues. 
 
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself! 

Purpose of the Team and About the Role 

Responsibilities: 

The purpose of the Regulatory Delivery Excellence (RDE) Submission Publisher role is to: 

 

  • Create and maintain regulatory registrations from candidate selection through end of product lifecycle. 

  • Create global registrations and provide maintenance support as needed for major markets. 

  • Meet customer requirements by optimizing business processes, tools and ensuring implementation of the regulatory agency’s preferred electronic common technical document (eCTD) specifications in a quality way to promote timely review by the regulatory agency. 

  • Build eCTD expertise and partners with Regulatory Associates, Regulatory Scientists, other publishing centres, vendors, and/or other contributing areas to align on submission specific requirements and to ensure adherence to submission regulations and guidelines. 

  

Requirements: 

Currently enrolled in 3rd level education and ready to pursue student placement  

Knowledge of drug development process

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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Marcus Rivera

Chief Revenue Officer

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