Deputy General Manager

Job Title

Job Grade

Department

Business Unit/ Division

Manager’s Job Title

Span of control

Direct

Total:

Reporting structure

Version and date

Area Of Responsibility

• 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.
  

Work Conditions

Physical Requirements

Education and Job Qualification

• 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.