Looking for high-growth Regulatory Affairs jobs in Bengaluru?
Indegene is hiring a Senior Regulatory Associate – CMC Authoring for experienced professionals with 4–8 years of expertise in CMC regulatory documentation, NDA/ANDA/MAA/BLA submissions, and global regulatory compliance.
This opportunity is ideal for candidates with strong experience in CMC Module 2.3 and Module 3 authoring, lifecycle management submissions, and regulatory operations across US, EU, ROW, and AFM markets.
If you have hands-on experience in eCTD authoring, regulatory CMC automation, and structured content authoring platforms, this role offers an excellent career progression in global regulatory consulting.
🔬 Job Overview
- Position: Senior Regulatory Associate – CMC Authoring
- Company: Indegene
- Location: Bengaluru, Karnataka, India (On-site)
- Experience Required: 4–8 Years
- Qualification: MBBS / PhD / MDS / BDS / MPharm / PharmD
- Employment Type: Full-time
This role focuses on authoring and reviewing CMC regulatory documents including drug substance and drug product sections for global submissions.
📌 Key Responsibilities
The Senior Regulatory Associate – CMC Authoring will:
- Author and review CMC Modules 2.3 and 3 for NDA, ANDA, MAA, BLA, and ROW submissions
- Prepare documentation covering manufacturing, formulation, stability, and quality controls
- Ensure compliance with ICH, FDA, EMA, WHO regulatory guidelines
- Coordinate with CMC, QA, Regulatory Affairs, Publishing & Manufacturing teams
- Conduct client calls and manage project status updates
- Support post-approval lifecycle management submissions
- Perform Root Cause Analysis (RCA) and implement CAPA
- Work in eCTD authoring and publishing environments
- Drive regulatory automation and digital authoring initiatives
- Ensure timely, high-quality regulatory submissions under strict deadlines
🎓 Qualifications Required
Eligible candidates must possess:
- MPharm / PharmD / MBBS / PhD / MDS / BDS
- 4–8 years of experience in CMC regulatory authoring
- Strong knowledge of:
- USFDA, EMA, WHO regulatory frameworks
- Global regulatory lifecycle management
- Clinical trial authorization procedures
- Document management systems and eApproval workflows
- Expertise in MS Word authoring, MS Excel & PowerPoint
- Experience in structured content or regulatory automation platforms (preferred)
💼 Why This Regulatory Affairs Job is Important
The Senior Regulatory Associate CMC Authoring role at Indegene is a strategic position within regulatory consulting. With increasing global regulatory scrutiny, companies require experts capable of delivering:
- Scientifically accurate CMC documentation
- Globally compliant eCTD submissions
- Automation-ready structured content
- High client satisfaction in regulatory operations
This position enhances exposure to global markets including US, EU, and ROW submissions, making it highly valuable for long-term regulatory career growth.
💰 Salary (Estimated)
Based on industry benchmarks for Senior Regulatory Affairs professionals in Bengaluru:
₹9,00,000 – ₹15,00,000 per annum (CTC)
(Salary may vary based on experience and skill level)
📍 Job Location
Bengaluru, Karnataka, India (On-site)
📢 How to Apply
