IQVIA, a global leader in clinical research, regulatory services, and healthcare intelligence, is hiring Regulatory Affairs Specialists with mandatory CMC (Chemistry, Manufacturing & Controls) experience. This is an excellent opportunity for experienced regulatory professionals to work on global submissions, CMC lifecycle management, and regulatory compliance in a hybrid work model.
These IQVIA Regulatory Affairs CMC jobs are open for professionals with 3 to 12 years of experience and are based in Bangalore, Hyderabad, and Thane. Candidates looking to advance their careers in global regulatory excellence and high-impact CMC roles should apply immediately.
Key Responsibilities – Regulatory Affairs CMC
- Prepare, review, and submit CMC regulatory documents for global markets (US, EU, ROW)
- Manage Chemistry, Manufacturing & Controls sections of regulatory submissions
- Support IND, NDA, ANDA, MAA, and post-approval variations
- Coordinate with cross-functional teams including QA, Manufacturing, and R&D
- Ensure compliance with ICH, FDA, EMA, and global regulatory guidelines
- Support regulatory strategy and lifecycle management activities
- Address regulatory queries related to CMC data and documentation
Required Qualifications & Experience
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or Life Sciences
- 3–12 years of hands-on experience in Regulatory Affairs CMC
- Strong knowledge of CMC documentation, regulatory submissions, and guidelines
- Experience working with global regulatory authorities
- Excellent communication, documentation, and stakeholder management skills
- Prior experience in CRO or pharmaceutical company preferred
Why Join IQVIA?
- Work with a global regulatory affairs leader
- Exposure to international regulatory submissions
- Hybrid work model for better work-life balance
- Career growth across multiple regulatory levels
- Collaborative and innovation-driven environment
Job Locations
- Bangalore, Karnataka
- Hyderabad, Telangana
- Thane, Maharashtra
(Hybrid Mode)
How to Apply
Interested and eligible candidates should share their updated CV via email or connect directly:
📧 Email: ajaykumar.s@iqvia.com
Early applications are encouraged as positions are limited.
