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Director Regulatory Affairs

Date: Jan 15, 2022

Location: West Chester, Pennsylvania, US, 00000

Company: Teva Pharmaceuticals

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

The Director, Regulatory Affairs, as part of the Global Specialty Regulatory Affairs Department is a strategic role that will be responsible for developing, coordinating, and implementing regulatory strategies for new biologic and small molecule products as well as marketed products. In this position you will support the development and lifecycle management of therapies for conditions in Teva’s Immunology portfolio including respiratory, oncology, and other therapeutic areas. The position requires regulatory knowledge of IND and NDA/BLA content and submission experience.  

 

Other duties:

  • Responsible for ensuring timely development of regulatory strategies through a global regulatory team approach for branded products.
  • Leads the team in planning, preparation, and execution of meetings with health authorities (e.g., FDA, EMA). Point-lead for interfacing with health authorities.
  • Regularly reports to management on progress against objectives and plans. 
  • Plans and directs projects and provides technical background, inspiration, leadership, regulatory intelligence, and consultation to cross-functional colleagues as well as members of the global regulatory team.
  • Lead facilitator for the submission and approval of regulatory applications and coordinates appropriate responses to health authorities to resolve outstanding regulatory issues.
  • Provides training and mentorship to regulatory staff. 
     

Qualifications

 

What you will bring to the role:

  • Bachelor’s degree in scientific field of study such as Biology, Chemistry or other related life science
  • Minimum 8 years of experience in pharmaceutical industry 
  • Minimum 5 years of experience in regulatory affairs working with filing and defense of major submissions such as IND/NDA/BLA/CLT/MAA


Preferred Qualifications:

  • PharmD, PhD or Master’s degree
  • Experience with eCTD
  • Working knowledge of relevant drug and biologic regulations and guidances

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Sr Director, Global Specialty Regulatory Affairs

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.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. 
Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As re