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Deputy General Manager
Sun Pharmaceutical Industries
posted 2mon ago
Job Role Insights
Key skills for the job
Job Description
- Actively involved in development, filing related activities for products assigned to team members.
- Pre-filing activities: Guidance/review of various correspondences with the agency like controlled correspondences, Pre ANDA, NDA meetings, HF, FOI requests, etc.
- Pre PIF-evaluation for US products.
- Regulatory operations: Shared goals, R&D Metrics, Approval calendar, QRM, Budget, Approval benchmarking, Portfolio management
- Cross functional team support to Baroda/Gurgaon/Princeton - Technical/guidance/providing information
- Work planning for Baroda team
- Ensuring team productivity and optimal utilization of resource
- Allocation of RA scientist to all DF products
- Recruitment, retention and development of talent
- Ensure timely and quality filing to ensure timely approval
- Managing changing requirements/expectations from the Agencies
- New process establishment for smooth functioning of department
- Creation and maintenance of various data base for ease of referencing, trend data analysis for management review
- Technical communication for dossier filing
- Resolution/trouble shooting/de bottlenecking wherever required during Pre-filing, filing and post filing.
- M. Pharm
- Having knowledge and good understanding of the filing requirements for ANDA/NDA/INDs, Query responses, Pre-filing development related activities, Pre PIF-evaluation for US.
- In-depth knowledge of filing requirements for ANDA/NDA/INDs, Pre-filing development related activities good understanding and interpretation of USFDA guidance s which helps to define correct strategy.
Employment Type: Full Time, Permanent
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What people at Sun Pharmaceutical Industries are saying
Rating based on 13 Deputy General Manager
reviews
Anonymous · Finance & Accounting
in Mumbai
Good. Good pay scales.
- Salary - Excellent
Promotions are slow. Other aspects are good.
Deputy General Manager salary at Sun Pharmaceutical Industries
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