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Regulatory Affairs Associate

Date: Jun 25, 2022

Location: Tel Aviv, IL, 1111

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

 

Teva's Regulatory Affairs team located at Tel Aviv are seeking for a  Regulatory Affairs Associate to lead and proactively manage all regulatory activities associated with development, registration and maintenance of Drug Master Files according to current international regulatory requirements.

**This is a temporary position

 

The role includes:

  • Support the life cycle management of APIs from RA perspective and resolve difficulties rose during development, review and commercialization periods
  • Review and approve ROS, specification and analytical control when required
  • Coordinate DMF preparation and related activities for On Time Submissions for all relevant markets
  • Proactively collaborates with the Regulatory Specialist team members, which support the submission or answer service requests
  • Prepare a DMF specific high level gap analysis report and proactively communicate any risk to the relevant departments. Follow up on the gaps' solving during the review period
  • Respond to deficiency letters and coordinate related activities

Qualifications

  • MSc at chemistry/biochemistry/biology or biotechnology - a must
  • PHD - An advantage
  • Relevant experience in regulatory affairs - an advantage
  • High level in English - must
  • Good human communications and High service approach to internal & external customers

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

Sr Mgr Regulatory Affairs, RA

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.