Job title: Regulatory Affairs Associate III – US Post approvals

Company: Teva Pharmaceuticals

Job description: 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

• Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual reports.
• Independently and proactively request documentation required for annual reports, compile, finalize and publish for managements review and subsequent dispatch to the Agency
• Independently work on simple supplements, compile and publish for managements review. Take a proactive approach for more complex submissions and contact internal stakeholders (when needed) to gain further insight on any given supplement. Convey findings to management and incorporate any.all applicable information in the submission to ensure a quality and a right first time submission.
• Assist management and proactively train Associate I’s and Associate II’s on guidance’s, internal processes, procedures, databases and trackers
• Other projects and duties as required/assigned

Qualifications

• BS in a scientific discipline or equivalent education and related experience
• Master’s degree in RA/QA discipline, a plus.
• Minimum four to five years pharmaceutical industry experience; Regulatory, Analytical, QA, laboratory or production experience preferred.

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

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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.

Expected salary:

Location: Navi Mumbai, Maharashtra

Job date: Fri, 22 Jul 2022 23:56:21 GMT

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