Senior Regulatory Associate - CMC Authoring

Why This Role Matters

The Senior Regulatory Associate – CMC Authoring plays a critical role in ensuring that pharmaceutical products meet global regulatory standards before and after market approval. With increasing scrutiny from international health authorities, accurate Chemistry, Manufacturing, and Controls (CMC) documentation is essential for successful product approvals and lifecycle management.
This opportunity at Indegene is ideal for experienced regulatory professionals who specialize in CMC Module 2.3 and Module 3 authoring, global submissions, and eCTD publishing. By delivering compliant and high-quality regulatory documents, this role directly supports timely product approvals across US, EU, ROW, and emerging markets.
Professionals in this role contribute to global healthcare access by ensuring scientifically accurate, well-structured, and regulator-ready submissions.

Job Description

Indegene is hiring a Senior Regulatory Associate – CMC Authoring in Bengaluru for candidates with 4–8 years of experience in regulatory documentation and global submission management.
The selected candidate will be responsible for authoring and reviewing CMC Modules 2.3 and 3 for NDA, ANDA, MAA, BLA, and ROW submissions. The role requires strong expertise in eCTD authoring, lifecycle management submissions, and cross-functional coordination with QA, Manufacturing, Regulatory Operations, and Publishing teams.
This position offers exposure to global regulatory markets and structured content authoring platforms, making it an excellent career growth opportunity in regulatory consulting.

Key Features of the Role:

• Position: Senior Regulatory Associate – CMC Authoring
• Location: Bengaluru
• Experience: 4–8 years
• Industry: Pharmaceutical Regulatory Consulting
• Global Exposure: US, EU, ROW, AFM markets
• Focus Area: CMC Module 2.3 & Module 3 Authoring
• Submission Types: NDA, ANDA, MAA, BLA
• Platform Experience: eCTD Authoring & Regulatory Automation

Responsibilities

• Author and review CMC Modules 2.3 and 3 for NDA, ANDA, MAA, BLA, and ROW submissions
• Prepare documentation covering manufacturing processes, formulation development, stability data, and quality controls
• Ensure compliance with ICH, USFDA, EMA, and WHO regulatory guidelines
• Coordinate with CMC, QA, Regulatory Affairs, Publishing, and Manufacturing teams
• Conduct client calls and provide project status updates
• Support post-approval lifecycle management submissions and variations
• Perform Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA)
• Work within eCTD authoring and publishing environments
• Drive structured content authoring and regulatory automation initiatives
• Ensure timely and high-quality regulatory submissions under strict deadlines

Required Qualifications

The role requires experienced regulatory professionals with strong scientific and documentation expertise.

Educational Requirements:

• M.Pharm, Pharm.D, MBBS, PhD, MDS. BDS

Experience and Skills:

• 4–8 years of experience in CMC regulatory authoring
• Strong expertise in CMC Module 2.3 (Quality Overall Summary) and Module 3 documentation
• Hands-on experience in NDA, ANDA, MAA, BLA submissions
• In-depth knowledge of global regulatory frameworks including USFDA, EMA, and WHO guidelines
• Understanding of global lifecycle management and post-approval variations
• Experience with eCTD authoring and publishing tools
• Familiarity with document management systems and eApproval workflows
• Proficiency in MS Word authoring, MS Excel, and PowerPoint
• Experience in structured content platforms or regulatory automation tools (preferred)
• Strong analytical, documentation, and communication skills
• Ability to manage multiple projects under tight timelines

alary Insights

Based on industry benchmarks in Bengaluru for Senior Regulatory Affairs professionals, the estimated salary range is:
₹9,00,000 – ₹15,00,000 per annum (CTC)
Compensation may vary depending on experience, technical expertise, client handling exposure, and regulatory market knowledge.

Company Overview

Indegene is a global healthcare solutions company specializing in medical affairs, regulatory consulting, commercialization services, and digital transformation for life sciences organizations. The company partners with pharmaceutical and biotech companies to accelerate product approvals and improve healthcare delivery worldwide.
With strong expertise in regulatory operations and digital innovation, Indegene provides professionals with opportunities to work on global submissions and cutting-edge regulatory automation platforms.

FAQs

Q1. Is experience in CMC Module 2.3 and 3 mandatory?
Yes, hands-on experience in CMC authoring is essential for this role.

Q2. Are freshers eligible?
No, this role requires 4–8 years of relevant regulatory experience.

Q3. Is global submission experience required?
Yes, exposure to US, EU, and ROW submissions is preferred.

Q4. Is eCTD knowledge mandatory?
Yes, experience in eCTD authoring and publishing environments is required.

Q5. Does this role involve client interaction?
Yes, candidates will participate in client calls and project discussions.

Application Tips

• Highlight specific experience in CMC Module 2.3 and 3 authoring
• Mention submission types handled (NDA, ANDA, MAA, BLA)
• Emphasize exposure to USFDA and EMA guidelines
• Showcase experience in lifecycle management and variations
• Prepare examples of handling tight regulatory timelines
• Demonstrate familiarity with structured content or regulatory automation tools