Looking for a Regulatory Affairs API job in Mumbai? Alivus Life Sciences is hiring Officer / Sr. Officer – Regulatory Affairs (API) for professionals experienced in DMF, ASMF, eCTD submissions, GDUFA, and EMA guidelines.
This is an excellent opportunity for candidates with 2–5 years of experience in API regulatory affairs, lifecycle management, and global regulatory submissions.
🏢 About the Company – Alivus Life Sciences
Alivus Life Sciences is a fast-growing pharmaceutical company specializing in API and finished dosage formulations. The company focuses on global regulatory compliance and high-quality submissions across US, EU, and other regulated markets.
📌 Job Details
- Position: Officer / Sr. Officer – Regulatory Affairs (API)
- Experience Required: 2–5 Years
- Salary: ₹3.5 – ₹6.5 LPA (as per experience)
- Location: Mumbai Suburban, Maharashtra
- Employment Type: Full Time, Permanent
- Industry: Pharmaceutical & Life Sciences
🎯 Key Responsibilities – Regulatory Affairs API
As a Regulatory Affairs Officer (API), your responsibilities will include:
- Preparation and compilation of Drug Master File (DMF) and ASMF
- Submission in eCTD format as per GDUFA and EMA guidelines
- Handling response to deficiency letters from regulatory agencies
- Lifecycle management of DMF including:
- Amendments
- Annual Reports
- Biannual Updates
- Preparation of Applicant’s Part for customers
- Resolving customer regulatory queries within timelines
- Ensuring compliance with ICH Guidelines, GDUFA, EMA requirements
This Regulatory Affairs API role demands strong technical knowledge in global regulatory documentation and submission strategy.
🎓 Educational Qualification
- MS / M.Sc (Science) – Any Specialization
- Strong regulatory documentation expertise preferred
💼 Required Skills
- DMF & ASMF Preparation
- eCTD Submission Management
- GDUFA & EMA Regulatory Knowledge
- ICH Guidelines
- Deficiency Response Preparation
- API Lifecycle Management
- Customer Query Handling
💰 Salary & Benefits
- Competitive salary: ₹3.5 – ₹6.5 LPA
- Exposure to global regulatory markets (US & EU)
- Experience in lifecycle management & regulatory strategy
- Career growth in API Regulatory Affairs
📈 Why This Regulatory Affairs API Job is Important
With increasing global regulatory scrutiny, professionals skilled in DMF preparation, eCTD submissions, and GDUFA compliance are in high demand. This role strengthens your profile for:
- Regulatory Affairs Manager – API
- Global Regulatory Strategy Roles
- USFDA & EMA Submission Specialist
If you’re planning long-term growth in Regulatory Affairs for API, this opportunity at Alivus Life Sciences can significantly enhance your career trajectory.
📩 How to Apply
