Medley Pharmaceuticals Hiring B pharma B sc M sc M pharma for Assistant Manager Regulatory Affairs

Medley Pharmaceuticals LtdRecruitment August 2020. Medley Pharmaceuticals Limited operates as a pharmaceutical company. The Company manufactures pharmaceutical formulations such as hematinics, anti bacterials, gynecology, cardiovascular, and other related drugs.

Medley Pharmaceuticals Hiring B pharma B sc M sc M pharma for Assistant Manager Regulatory Affairs

Important Vacancy details:

  • Post Name: Assistant Manager -Regulatory Affairs
  • Education :B.pharma,,,M.pharma
  • Experienced:05 to 10 years
  • Location: Daman & Diu
  • Salary : NA
  • Openings :NA
  • Recruiter Name:Keval Patel

 Job Description: We have requirement for the post of Assistant Manager -Regulatory Affairs in Medley Pharmaceuticals Ltd !

  • Coordination and review for administrative data required for dossier submission.
  • Coordination with Production, Store, QC and R&D for archival of regulatory samples, packing component, Working standard & analytical data
  • Monitoring of New Material Introduction and New Product Introduction activities for ANDA & EU Dossiers.
  • To prepare requirement for FDA applications related to FSC, COPP, additional product license, tender documents etc.
  • To maintain license documents and other FDA documents.
  • Review and Co-ordination for the Gap Analysis for the Regulatory News Letters and follow ups for the closures of identified actions.
  • Coordination, tracking and follow up with production and IPQA concerned for Sample requirement for various countries.
  • Providing registration details along with registration certificates to plant concerns in coordination with RA-HO.
  • Review and issuance of Registration compile status and respective addendum to all plant concerns within stipulated period.
  • Reviewing and approval of product conversion form for different country based on need of International business in coordination with Regulatory Affairs –HO.
  • Reviewing and approval of BMR, BPR on behalf of Regulatory affairs.

Selection Process: The selection will be on the basis of Interview.

How to Apply Click here for full details and Apply Online

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