Summer Intern - Regulatory Affairs

2019 Summer Internship Program Madison, New Jersey


Description

Now is an exciting time to join LEO Pharma, a leading global healthcare company specializing in dermatology. For more than a century, our products, which are marketed in more than 100 countries worldwide, have improved millions of people's lives around the world. We are a company united by strong values – passion, customer focus, innovation, adaptability and integrity. Our values reflect the way we strive to improve the quality of life for patients, and are at the heart of our company’s success and growth. Our global team – consisting of approximately 4,800 people in 61 countries worldwide – is LEO Pharma’s greatest asset. With an incredible mix of people from different cultures and backgrounds, LEO Pharma is a workplace where passion and innovation thrive and people grow. We continue to seek passionate, dedicated, and solutions-oriented people – and consistently ensure that our people develop their talent. If LEO Pharma is to realize its vision, we need people who think innovatively and act with integrity. Together, we can embrace change and grasp strategic business opportunities. The result: life-enhancing products that bring real value to patients.

As part of our 2019 Summer Intern program, you will support the LEO Pharma US Regulatory Affairs Team. 

What will you do

  • Provide support for the BLA submission of tralokinumab and ongoing review of the JAKi phase 2 studies. Gain in-depth understanding of the documents required for an IND, Pre-NDA meeting and NDA submission. 
  • Gain in-depth understanding of the role of the various regulatory functions involved in the pre-approval preparation for tralokinumab.
  • Acquire knowledge regarding the interdependencies of various functions (ie. regulatory, legal, medical, global marketing, US marketing) in the preparation of the BLA submission of tralokinumab.
  • Acquire hands-on knowledge of FDA requirements for the preparation and submission of promotional materials.
  • Assist in the development of Artwork (prescribing information, cartons, etc) to ensure compliance with FDA regulations, specifically as it relates to the transfer of ownership of Segrate.
  • Complete a project related to regulatory affairs as determined by department.

Qualifications:

  • Must be current college student Junior/Senior or recent college graduate with a major in either: Life Sciences, Information Technology or Business. Students pursuing a Masters or PharmD is a plus.
  • Strong written, verbal communication skills
  • Good organizational, problem solving, analytical and time management skills
  • Proficient in MS Office programs including Excel, and PowerPoint

You are
Passionate, collaborators, inspiring, energetic and entrepreneurial.