AstraZeneca is currently hiring experienced professionals for International CMC Regulatory Affairs Manager I & II roles in Bangalore, India. This is a high-impact opportunity for regulatory professionals specializing in Chemistry, Manufacturing & Controls (CMC) to work on global submissions and lifecycle management of innovative medicines.
If you have strong expertise in regulatory CMC submissions, dossier preparation, and global health authority interactions, this role offers exposure to end-to-end drug development and international regulatory strategy.
๐ Job Overview
- Role: International CMC Regulatory Affairs Manager I & II
- Company: AstraZeneca
- Location: Bangalore, India
- Experience:
- Manager I: 8+ years
- Manager II: 10+ years
- Job Type: Full-time
- Mode: Hybrid (3 days office)
๐ฏ Key Responsibilities (CMC Regulatory Affairs)
๐ CMC Submission & Documentation
- Prepare, author, and manage CMC modules (Module 3) for regulatory submissions
- Ensure submission-ready documentation aligned with global standards
- Support MAA, IND, CTA, and post-approval variations
๐ Regulatory Strategy & Lifecycle Management
- Lead CMC regulatory strategy across product lifecycle
- Handle post-approval changes, variations, renewals
- Apply regulatory intelligence to optimize submission content
๐ Project & Stakeholder Management
- Manage cross-functional teams (QA, Manufacturing, R&D)
- Ensure timely delivery of submissions
- Communicate updates to global stakeholders
๐ Compliance & GxP
- Ensure compliance with ICH, GxP, and global regulatory guidelines
- Maintain health authority communication records
- Support risk management and change control
๐ Eligibility & Qualifications
โ Essential
- Degree in Pharmacy / Life Sciences / Chemistry / Biology
- Experience:
- Manager I: 8+ years
- Manager II: 10+ years
- Strong knowledge of:
- CMC regulatory requirements
- Global submissions (US, EU, ROW)
- Drug development lifecycle
โ Skills Required
- Regulatory writing & dossier preparation
- Project management & stakeholder coordination
- Strong analytical & problem-solving skills
- IT proficiency (Regulatory systems/tools)
โ Desirable
- Experience in eCTD submissions
- Knowledge of manufacturing regulations
- Lean / process optimization exposure
๐ผ Why Join AstraZeneca?
- Work on global regulatory submissions
- Exposure to full product lifecycle (development to post-marketing)
- Collaborate with cross-functional global teams
- Opportunity to influence life-changing therapies
- Strong career growth in regulatory strategy
๐ฐ Salary Insight (India Market Estimate)
- Manager I: โน18 โ โน28 LPA
- Manager II: โน28 โ โน45 LPA
(Based on industry benchmarks for CMC regulatory roles in India)
๐ Job Location
- Bangalore, Karnataka, India (Hybrid Work Model)
๐ How to Apply
Application Link for International CMC Regulatory Affairs Manager I
Application Link for International CMC Regulatory Affairs Manager II
