Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Associate Manager -II, Reg CMC
• Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities.
• In addition interact with HA's on REG CMC questions to support new product or post marketed launches.
• Author high -quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines.
• Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e -publishing requirements.
• Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• As needed, coordinate /collect/store source documentation needed for direct submission to Health Authorities.
• Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
• Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
• Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent Desirable: Advanced Science Degree with a minimum industrial experience of 4 years in Pharmaceutical Industry
• Operational Excellence
• Stakeholder Engagement
• Project Excellence Continuous Learning (Dyn. Knowledge Development)
• Interpersonal Savvy
• Operations Management and Execution Project Management Collaborating across boundaries Cross Cultural Experience
• High level understanding of Regulatory quality, standards and policies
Experience : 4 years
Qualification : B.Pharm, B.Sc
Location : Hyderabad, AP
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Research & Development
End Date : 30th September, 2020
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