Teva Pharmaceuticals, a global leader in generic and specialty medicines, is hiring a Regulatory Affairs Associate I at its Navi Mumbai location. This opportunity is ideal for M.Pharm Regulatory Affairs or QA professionals with prior experience in FDA submissions, ANDA annual reports, and change control documentation.
If you are looking to build a long-term career in US Regulatory Affairs jobs in India, this Teva Regulatory Affairs Associate vacancy offers strong exposure to FDA regulations, ANDA lifecycle management, and global compliance systems within a multinational pharmaceutical environment.
Job Overview
Job Title: Regulatory Affairs Associate I
Company: Teva Pharmaceuticals
Location: Navi Mumbai, Maharashtra
Job ID: 65573
Job Type: Full-time
Experience Required: Minimum 2 years
Industry: Pharmaceutical / Biopharmaceutical
Function: Regulatory Affairs – US FDA
Key Responsibilities
As a Regulatory Affairs Associate I at Teva, your responsibilities will include:
Preparing ANDA Annual Reports, supplements, and amendments in compliance with US FDA guidelines
Supporting change control evaluations and reviewing supporting documents such as:
Batch manufacturing records
Analytical methods
Specifications and validation documents
Maintaining regulatory databases, trackers, and submission logs in real time
Assisting senior regulatory staff in FDA filing determinations
Ensuring approved applications remain FDA-compliant throughout the product lifecycle
Participating in cross-functional regulatory and quality projects as assigned
This role provides hands-on experience in US regulatory submissions, making it a strong stepping stone for career growth in global regulatory affairs.
Required Qualifications & Experience
Educational Qualification
M.Pharm in Regulatory Affairs or Quality Assurance (preferred)
Experience
Minimum 2 years of experience in Regulatory Affairs, OR
Experience in QC, Analytical, R&D, Manufacturing, or Pharmaceutical Production with regulatory exposure
Key Skills
Knowledge of FDA regulations and ANDA processes
Proficiency in MS Word, Excel, and regulatory documentation tools
Strong written and verbal communication skills
High attention to detail and ability to manage multiple priorities
Ability to work independently and in cross-functional teams
Why Join Teva Pharmaceuticals?
Teva offers a supportive and growth-driven work environment with:
Competitive salary and performance-based rewards
Flexible working arrangements (role-dependent)
Generous paid leave and wellbeing programs
Access to “Twist” – Teva’s global career development platform
Continuous learning, internal mobility, and leadership development opportunities
A diverse, inclusive, and ethical workplace culture
Salary (Estimated)
₹6,00,000 – ₹9,00,000 per annum (based on experience and industry benchmarks for RA roles in Navi Mumbai)
