“Urgent requirement Regulatory Affairs”

  • Company:
    Saga Laboratories
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    1 week ago
  • Category:
    Biotechnology/Pharmaceutical/Medicine | Healthcare

Skill: Good Analytical Skill , Able to grasp easily , good management; Exp: 1-3 years; Preparationof dossiersas perACTD, CTD,Country specificguidelines. Preparation ofthe re-registrationdocuments Replying toqueries forvarious countries. Checkingdossiers, artworks,and technicaldocuments. Preparation ofProduct permission,Free SaleCertificate andCertificate ofPharmaceutical Product(COPP) &oth erFDCA relatedwork. Prepare& Reviewof technicaldocuments like,Specifications, Certificateof Analysis,Test Methods,Testing Rep orts, ValidationReports, BatchRecords, StabilityProtocols, StabilityData, andProduct DevelopmentReport Coordinate withvarious departmentsto collectthe documentsfor dossierpreparation. Review ofthe qualityand analyticaldata asper pharmacopeia

Formulation | Regulatory Affairs

Degree: M.Pharm. (Pharmacy)

Experience: 1-3

Function: Biotech / Pharma / R&D | Medical / Health / Fitness