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Teva Pharmaceuticals Regulatory Affairs Associate I - US Post approval in Navi Mumbai, India

Regulatory Affairs Associate I - US Post approval

Date: May 5, 2023


Navi Mumbai, India, 400706

Company: Teva Pharmaceuticals

Job Id: 44506

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

  • Under direct supervision, prepare annual reports, and as experience is gained, assist in supplements for FDA submissions.

  • Under direct supervision, review documents included as support to change controls (i.e. as side by side review of batch records, methods, specifications etc.) for adequate review of the quality and appropriateness of the change control.

  • Familiarizing oneself with applicable FDA Regulation and guidance to learn about filing determinations as they are used on the change control process.

  • Other projects and duties as required/assigned.

  • Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual Reports.


  • Bachelor’s degree in a scientific discipline, required.

  • Master’s degree in RA/QA discipline, a plus.

  • Minimum One to two years Regulatory Affairs experience and/or analytical/QC, R&D/laboratory or production experience in pharmaceutical/biotech industry


Regulatory Affairs

Sub Function

Medical 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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

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.

EOE including disability/veteran