Teva Pharmaceuticals Hiring Regulatory Affairs Associate I in Navi Mumbai

Teva Pharmaceuticals Is Hiring: Regulatory Affairs Associate I

Location: Navi Mumbai, India (400706)
Job ID: 65574

About Teva Pharmaceuticals

Teva Pharmaceuticals is a global leader in generic medicines and a trusted producer of many products listed on the World Health Organization’s Essential Medicines List. With operations in nearly 60 countries, Teva’s mission is to make good health more affordable and accessible. Every day, more than 200 million people worldwide rely on Teva medicines—making a meaningful impact on global healthcare.

Job Overview

Teva Pharmaceuticals is seeking a Regulatory Affairs Associate I to join its Regulatory Affairs team in Navi Mumbai. This role is ideal for professionals with foundational regulatory experience who are eager to grow their expertise in FDA submissions and ANDA maintenance within a global pharmaceutical organization.

Under direct supervision, the Associate will support regulatory submissions, primarily focusing on ANDA Annual Reports, supplements, and amendments, while ensuring compliance with FDA regulations.

Key Responsibilities

• Prepare and submit ANDA Annual Reports in accordance with FDA guidelines

• Assist in the preparation of regulatory supplements and amendments as experience increases

• Review supporting documents for change controls, including batch records, specifications, and analytical methods

• Support evaluation of change controls to ensure regulatory accuracy and compliance

• Maintain regulatory databases, trackers, and approved applications in real time

• Develop working knowledge of FDA regulations and guidance related to filing determinations

• Support additional regulatory projects and tasks as assigned

Qualifications & Experience

• M. Pharma degree in Regulatory Affairs or Quality Assurance (preferred)

• Minimum 2 years of experience in Regulatory Affairs or related pharmaceutical functions such as QC, R&D, analytical labs, or production

• Basic proficiency in MS Word, Excel, and internet-based systems

• Strong organizational skills with attention to detail

• Ability to multitask and manage changing priorities

• Good written and verbal communication skills

• Ability to work independently as well as collaboratively in teams

Why Join Teva?

• Opportunity to work with a global pharmaceutical leader

• Exposure to FDA regulatory submissions and ANDA lifecycle management

• Career growth in Regulatory Affairs within a structured and supportive environment

• Contribute to medicines that improve lives across the world

📍 Location: Navi Mumbai
🏢 Company: Teva Pharmaceuticals
🆔 Job ID: 65574

If you are passionate about regulatory compliance and want to grow your career in the pharmaceutical industry, this opportunity at Teva Pharmaceuticals could be the right next step.

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