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Deputy General Manager
Sun Pharmaceutical Industries
posted 2mon ago
Job Role Insights
Flexible timing
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
What Sun Pharmaceutical Industries employees are saying about work life
Sun Pharmaceutical Industries Benefits
Health Insurance Job Training Free Transport Soft Skill Training 
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