Regulatory Affairs Associate I Job at Teva Pharma | US FDA & ANDA | Navi Mumbai

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Regulatory Affairs Associate I

Teva Pharmaceuticals

Navi Mumbai

2+ Years

Regulatory Affairs

US FDA / ANDA

Full-Time

🏢 About Teva Pharmaceuticals

Teva Pharmaceuticals is one of the world’s leading generic and specialty medicine companies, supplying high-quality medicines across global markets.

With strong regulatory expertise and global FDA-compliant manufacturing operations, Teva offers excellent career growth in US Regulatory Affairs, ANDA lifecycle management, and global compliance systems.

📌 Job Overview

Position: Regulatory Affairs Associate I

Location: Navi Mumbai, Maharashtra

Experience Required: Minimum 2 Years

Qualification: M.Pharm (Regulatory Affairs / QA Preferred)

Industry: Pharmaceutical / Biopharmaceutical

Function: US FDA Regulatory Affairs

🧾 Key Responsibilities

Prepare ANDA Annual Reports, supplements, and amendments as per US FDA guidelines
Support change control evaluations and regulatory impact assessments
Review Batch Manufacturing Records (BMR), analytical methods, and validation documents
Maintain regulatory trackers, submission logs, and compliance databases
Assist senior RA staff in FDA filing determinations and strategy
Ensure ANDA lifecycle compliance post-approval
Coordinate cross-functionally with QA, QC, Manufacturing, and R&D teams
Support documentation during audits and inspections

🎓 Required Qualifications

M.Pharm in Regulatory Affairs or Quality Assurance (Preferred)
Minimum 2 years of Regulatory Affairs experience
OR exposure to QC, R&D, Manufacturing with regulatory involvement
Strong knowledge of US FDA regulations and ANDA processes
Proficiency in MS Word, Excel, and regulatory documentation systems

💼 Why Join Teva?

Exposure to US FDA regulatory submissions
Work on ANDA lifecycle management
Competitive salary & performance rewards
Global learning platform (Twist Career Development)
Inclusive and compliance-driven work culture

💰 Salary (Estimated)

₹6,00,000 – ₹9,00,000 per annum (Industry benchmark for 2+ years RA professionals in Navi Mumbai)

📌 Note Before You Apply:
Kindly read the entire job description carefully before applying. Make sure your qualifications and experience align with US FDA, ANDA, and Regulatory Affairs requirements.

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