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.