Associate Manager require at Novartis

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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

Job Description
• 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.

Candidate Profile
• 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

Additional Information
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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