Deputy General Manager

2 days ago

Vadodara, Gujarat, India SUN PHARMA Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Job Title
Group Leader US & OAM

Job Grade
G8

Department
Regulatory & Business Continuity

Business Unit/ Division
R&D Baroda

Manager's Job Title
Group Leader Regulatory & Business continuity for US/OAM

Span of control
Direct
Total:
6

Reporting structure
Direct to Head

Job Description
Version and date
1.0 / 10-Oct-24

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.

Geographic Scope/ Market

US, EU, Japan, Australia, Canada

Work Conditions
Full time

Physical Requirements
Presence at work

Travel Estimate

Infrequent

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.

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