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Regulatory Affairs Associate

0-1 years
Not Disclosed
10 March 19, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Person will responsible for Compilation/ review of supplements ( including Injectable and OSD dosage form) ,Global Annula reports, preparation of summary documents for regulatory submission

 

 

  • Preparation, Review and Submission of Amendments and supplements for the assigned products
  • Prepation of Summary documents for Regulatory submisison
  • Preparation, Review and Submission of response to the Agency’s queries for the assigned products
  • Compilation and submission of Global Annual Report.
  • Review of stability protocols and reports, analytical method validation protocols and reports.
  • Review of raw material, packaging material, finished product specifications, finished product stability specification and testing procedure.
  • Review of batch records.
  • Review of Process Validation Protocol, hold time study protocols and Repots
  • Review of Product Development Report
  • Review of executed documents including executed BMR, Certificate of Analysis to ensure the compliance with regulatory requirement

About Us

Be the change you wish to see. Come join us! We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.