Novartis Recruitment July 2020.Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Our healthcare portfolio is strategically aligned to deliver positive impact to our patients
Important Vacancy details:
- Post Name: Associate Manager – I, Regulatory Affairs
- Education : Degree in Science
- Experienced:4 years
- Location: Hyderabad, AP
- Salary :NA
- Openings :NA
Job Description: We have requirement for the post of Associate Manager – I, Regulatory Affairs in Novartis !
• 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 regulatory submissions throughout the product lifecycle.
• Apply 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.
• 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.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online