Pharm'Up 
Novartis is currently recruiting for an RA CMC Associate Manager-II to manage regulatory activities related to Chemistry, Manufacturing, and Control (CMC). This role is crucial for ensuring the regulatory compliance of both new and existing pharmaceutical products and is based in Hyderabad.
Position and Application Details
| Post Title | Location | Functional Area | Industry Type | End Date |
| RA CMC Associate Manager-II | Hyderabad (Office) | Research & Development (R&D) | Pharma/Healthcare/Clinical research | 20th October 2025 |
Role Summary: Global Regulatory Compliance
The Associate Manager-II will be responsible for preparing and publishing CMC documentation for submissions to global Health Authorities (HAs). This role ensures that all documentation aligns with global regulatory strategies and current guidelines, supporting the entire product lifecycle from clinical studies to post-market variations.
Core Responsibilities
- Documentation Authoring: Authoring high-quality global CMC documentation for Health Authority submission, ensuring technical congruency and regulatory compliance.
- Submission Strategy: Applying agreed-upon CMC global regulatory strategies and identifying the required documentation for global submissions.
- Stakeholder Negotiation: Identifying content, quality, or timeliness issues and negotiating the delivery of approved technical source documents with internal and external stakeholders to meet project timelines.
- HA Interaction: Supporting interactions with Health Authorities by coordinating and collecting necessary source documentation and helping address CMC questions.
- Regulatory Systems: Performing administrative activities like data entry into the Regulatory Information Management System (RIM) and other CMC databases.
- Compliance: Contributing to the global RA CMC team, sharing lessons learned, and ensuring all regulatory documentation meets Novartis and international guidelines.
Required Skills and Experience
Novartis is looking for a candidate with strong foundational knowledge and professional competencies in a regulated environment:
- Core Skills: Documentation Management, Regulatory Compliance, Operational Excellence, and Life Sciences background.
- Soft Skills: Cross Cultural Experience, Project Management, Operations Management and Execution, and Collaborating Across Boundaries.
This is an opportunity to join a company with one of the industry’s most exciting product pipelines, working at the core of global regulatory affairs.
About the Author
