skillindiajobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Sr. Manager/AGM Regulatory Affair - US Market

15.00 to 24.00 Years   Mumbai City   22 Dec, 2021
NMS Consultant Hiring For Leading Pharma Company
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryNot Mentioned
Functional AreaNot Mentioned
EmploymentTypeFull-time

Job Description

  • Preparation and review of Supplements for post approval changes of ANDA
  • Ensured to have post approval compliance at risk based assessment. (i.e., determining and Evaluating appropriate fling category.)
  • Review of all the technical documents required for post approval changes
  • Ensuring all compiled post approvals are in compliance with current FDA thinking and expectations to minimize the deficiencies.
  • Ensure timely submission of Annual reports for all approved products as per annual report submission time line.
  • To track all changes from time to time in the annual report period of approved products and ensure submission of all changes to FDA (without missing any) with detailed change histories
  • Ensure all annual reports are in compliance with current FDA thinking and expectations.
  • Evaluation and approval of post approval changes change control for in compliance with current FDA thinking and expectations
  • Evaluation of Change control / deviation and review of technical documents in its support
  • Review of technical documents required for ANDA compilation
  • Ensuring all compiled ANDAs are in compliance with current FDA thinking and expectations to minimize the deficiencies.and CBE and ensure that it is meeting current FDA thinking)
  • Ensured to have post approval compliance at risk based assessment. (i.e., determining and Evaluating appropriate fling category.)
  • Review of all the technical documents required for post approval changes
  • Ensuring all compiled post approvals are in compliance with current FDA thinking and expectations to minimize the deficiencies.
  • Ensure timely submission of Annual reports for all approved products as per annual report submission time line.
  • To track all changes from time to time in the annual report period of approved products and ensure submission of all changes to FDA (without missing any) with detailed change histories
  • Ensure all annual reports are in compliance with current FDA thinking and expectations.
  • Evaluation and approval of post approval changes change control for in compliance with current FDA thinking and expectations
  • Evaluation of Change control / deviation and review of technical documents in its support
  • Review of technical documents required for ANDA compilation
  • Ensuring all compiled ANDAs are in compliance with current FDA thinking and expectations to minimize the deficiencies.

APPLY NOW

Sr. Manager/AGM Regulatory Affair - US Market Related Jobs

© 2020 Skillindia All Rights Reserved