Harman Finochem Ltd Recruitment Regulatory Affairs (formulation) R and D For BPharma , MPharmacy

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Harman Finochem Ltd Recruitment Regulatory Affairs (formulation) R and D For BPharma , MPharmacy

Vacancy details:
  • Post Name: Regulatory Affairs (formulation) R&D
  • Qualification: B.Pharma , M.Pharmacy
  • Experience:5 – 7 years
Job Description: We have requirement for the post of Regulatory Affairs (formulation) R&D in Harman Finochem Ltd!
  • 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.
    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).
    Well expertise in handling eCTD Applications like Citrix-LORENZ docuBridge, labelBridge (Structured Product Labeling (SPL)).
    Responsible for the most of projects in the Regulatory Affairs Submission for Labeling.
    Can work with a team/independently on any project like ANDA/ANDS for US and Health Canada.
    Planning & execution of experiments/ pilot batches, Reference listed drug (RLD) characterization.
Important details: 
  1. Location: Aurangabad
  2. Salary :Not Disclosed
  3. Openings : NA
Company Info : Address 107-A Vinay Bhavya Complex 159 A CST Road, Kalina, MUMBAI, Maharashtra – 400098,India Contact Person: Swati Thorat
Phone Number: 02406605612
Selection ProcessThe selection will be on the basis of Interview.

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