Regulatory Affairs job at Haleon as CMC Associate, Apply online!
About Haleon Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creatin
g. And a culture that’s uniquely ours. Care to join us. It isn’t a question.Location: India – Andhra Pradesh – Hyderabad
Employment Type: Full-time
Posted On: Posted Today
End Date: June 27, 2025
Job Requisition ID: 532311
Job Purpose: The purpose of this role is to execute CMC regulatory activities for new product registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products.
Key Responsibilities:
- Responsible for CMC regulatory matters relating to registrations and/or maintenance of business activities.
- Preparation of CMC sections of new registration files, TMACs, briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions, and other documents as needed.
- Interacts with colleagues in other global functions to deliver high-quality CMC dossiers, TMACs, documents & materials to local Regulatory Affairs.
- Applies processes and procedures to maintain up-to-date technical product records/information.
- Provides CMC evaluations for potential changes and ensures regulatory compliance.
Preferred Skills & Qualifications:
- Degree in a pharmaceutical or life science or equivalent regulatory experience.
- 3-5 years’ experience in Regulatory Affairs.
- Knowledge in Quality, product development, manufacturing, experience in systems, regulatory information management, compliance, and ideally OTC experience.
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