23 days old

Manager Regulatory Affairs, Strategy

West Chester, PA 19380

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Around 200 million people worldwide take one of our medicines every day. In the United States, where Teva is the leading generic pharmaceutical company, one out of every nine prescriptions is filled by a Teva product. In the UK it is one out of every six and in Canada it is one out of every six. In addition, many prescription medications made by other companies include active pharmaceutical ingredients produced by Teva.

 

As the RA Manager you will be required to lead in the operational execution of submissions to Health Authorities, including product specific correspondence as well as normal maintenance activities. 

 

In addition, you will work with your supervisor or take the lead in the development, coordination, and execution of regulatory strategies for new product development as well as marketed drug products. You will critically review submission documents and, with supervision, prepare high quality regulatory submissions to the FDA.  

 

For this position you will have previous experience supporting regulatory activities. 

 

10% domestic/international travel required to attend meetings with FDA, conferences, etc.

Qualifications

What you will bring to the role:

  • Bachelors degree in Biology or other related life science
  • Minimum 2 years of pharmaceutical industry experience in new drug related product strategy and submissions, including working knowledge of FDA regulations and guidance for new drugs
  • Minimum 2 years leading preparation of Health Authority submissions

 

Preferred Qualifications:

  • Experience with leading and/or supporting IND, NDA and/or BLA filings
  • Working knowledge of FDA regulations and guidances
  • Experience with FDA/ICH Guidance and eCTD
  • Proficient in project management
  • Able to evaluate critical data in order to identify cause of problem

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Director, RA, Global Neurology, Pain & Migraine

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Categories

Posted: 2021-02-05 Expires: 2021-03-07

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Manager Regulatory Affairs, Strategy

Teva Pharmaceuticals
West Chester, PA 19380

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