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Team Lead Regulatory Affairs

Date:  Jan 27, 2023
Location: 

Kfar Saba, Israel, 11

Company:  Teva Pharmaceuticals
Job Id:  39022

Who are we?

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

  • Maintenance and management of post approval registration files intended for different global areas, including preparation and submission of change supplements and variations, annual reports, license renewals.  Responsible of an area in the RA department.
  • Support for initial R&D submissions for different global areas, including registration file preparation and response to health authorities information requests – depending on products and fields
  • Prepare and Coordinate the submission plan and working plan for the area under responsibility and ensure it is executed.
  • Manage RA team members. Follow up  on performance of the team members.
  • Handling change controls to provide regulatory strategies, assessments and requirements.
  • Regulatory guidance.
  • Work with various interfaces in Israel and abroad including EU, US, Canada in a complex work environment. Participation in meetings at the local and global level.
  • Coordinate with RA members abroad on submissions and assessments
  • Set up working procedures, participation in new work procedures development or improvement.
  • Work that requires creative thinking, team work, multi-tasks management and high responsiveness, tasks and personnel management skills.

Qualifications

  • Education – B.Sc. or M.Sc. in Pharmacy/Life Sciences/Chemistry/Biology – must.
  • English at a very high level - speaking, reading and writing – must.
  • Experience in registration in the field of pharmaceuticals or medical device – must. (High advantage to pharmaceuticals regulatory experience)
  • Familiarity with the various regulatory requirements– must. Experience in post-approval regulatory requirements and submissions for pharmaceuticals and in working with health authorities in particular FDA and EU countries – must
  • Familiarity with the regulatory requirements for sterile, biological and combination products – high advantage.
  • Writing and analyzing skills
  • Experience in managing a small team – high advantage

 

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Dir Regulatory Affairs, Registration

Already Working @TEVA?

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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.