Job Summary

Regulatory Affairs CMC Manager

The purpose of this role is to execute CMC regulatory activities for new products registrations and life-cycle maintenance (including variations and renewals) for a defined portfolio of products.

Role Responsibilities

- Responsible for CMC regulatory matters relating to registrations and/or life-cycle maintenance of business activities (including variations and renewals) for assigned product portfolio. Preparation of CMC sections of current registration files, PIFs, MDTFs, briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions.
- Interacts with colleagues in other global functions (e.g. Category, BU, Quality and Supply Chain) to deliver high quality CMC sections for dossiers, PIFS or MDTFs including documents & materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance.
- Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.




- Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records e.g. change controls.
- Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions. Develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends.

Basic Qualifications

- Specialisation in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
- 5 to 6 plus years experience in Regulatory Affairs.
- Knowledge in Quality, product development and manufacturing

Preferred Qualifications

- B Pharm or B Sc , M Pharm, Masters (MBA , MS, MA), or PhD/PharmD/JD QP

Location - this role is based in: Hyderabad

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Manager- Global Regulatory Affairs CMC (Hyderabad)
🏢 Haleon
📍 Hyderabad