Deputy General Manager
SUN PHARMA
Date: 3 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
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
US, EU, Japan, Australia, Canada
Work Conditions
Full time
Physical Requirements
Presence at work
Travel Estimate
Infrequent
Education and Job Qualification
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.
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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