Harman Finochem Ltd Recruitment 2019- :Harman Finochem Ltd Recruitment 2019 for the position of Officer in Regulatory Affairs (formulation) .Please go through following summary of vacancy. Please check at bottom of the this Summary of vacancy for more details and apply on source web page.
|Post Name||Officer in Regulatory Affairs (formulation)|
|Salary||Not Disclosed by Recruiter|
|Time & Venue||NA|
Opening date: 13/08/2019
Job Description: -1. Planning, review and execution of daily submission (Pre-Approval and Post Approval) ANDA/ANDS, SANDS, PM Safety Update, CBE-0/CBE-30, Level III /Annual Reportable changes. 2. Submission of Responses to Deficiencies (response to clarification requests) received from Regulatory agencies (USFDA/Health Canada), Responsible for maintaining Track wise – Change Control records (CCRs) and Track wise Regulatory Information Management System (RIMS) records. 3. Responsible for All Post Approval and Commercialization Activities (including ERS Approval, Initiation of Blue Software request (Artwork management system)) of PMs and Labels. Submission of Pristine PMs / Final PMs (English and French to Health Canada). 4. Well expertise in handling eCTD Applications like Citrix-LORENZ docuBridge, labelBridge (Structured Product Labeling (SPL)). 5. Responsible for the most of projects in the Regulatory Affairs Submission for Labeling. 6. Can work with a team/independently on any project like ANDA/ANDS for US and EU market.
About Company : Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe. Established by Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Allopurinol, Fenofibrate, Divalproex Sodium, Phenobarbital/Phenobarbitone, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more.