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)
How to Apply
