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Regulatory Affairs(Complex Injectables) For pharma Company in Hyd

4.00 to 7.00 Years   Hyderabad   04 Feb, 2021
BVR People Consulting
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Roles and ResponsibilitiesJob Title: Regulatory Affairs(Complex Injectables) Company: Leading Pharma Company in Hyderabad Location Designation: Sr Executive to Assistant ManagerNo. of Positions: 5Division: R&D Department: Regulatory Affairs Job Location:Hyderabad Location Qualification: MSc/ M.PharmaYears of Experience:4 to 7 Years Salary Range: 10 LPAContact person: Mr.Zabi Moghal Mobile: 7676936384 Email: zabi@bvrpc.com

  • Preparation of ANDAs/ 505(b)(2) /EU Dossiers/ ANDSs for US, EU & Canada market as per regulatory requirements
  • Review of master documents and reports (Specifications , PDR, Manufacturing and Packing Batch records, artworks, PVP, PVR, Protocols) for ANDAs/EU Dossiers/ ANDSs and deficiency response
  • Coordinate with internal CFTs (R&D, AR&D, SCM, API-RA etc) as well as external counterparts (i.e. manufacturing and testing sites etc) as RA SPOC
  • Preparation of deficiency response. Co-ordinate with CFTs, track the action items and review the documents for deficiency response
  • Identify all open issues at respective stage of product development, ANDA filing and deficiency responses in consultation with team lead/ vertical head
  • Provide support to commercial launch team w.r.t review of documents (like labels, batch records, Stability protocols, PVPs etc), preparation of tech-pack and PLAIR submission.
  • Co-ordination with internal as well as external counterparts as RA SPOC for timely preparation of ANDA and deficiency response
  • Evaluation of CRNs and categorization of changes as per regulatory guidelines
  • Regular tracking of new guidances and change in regulations
  • Preparation of site transfer packages
Mandatory Skills:
  • Good knowledge of current regulatory guidelines (ICH, FDA, EMEA etc),
  • Good understanding of Injectables DP manufacturing, Sterilization, Media fill etc.,
  • Reasonable understanding of submission requirements of US, EU & Canada,
  • Good understanding of Pharmaceutical manufacturing and product development,
  • Good Technical writing skills for Dossier and deficiency response preparation.
Salary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical Research Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology Role Category: Drug Regulatory Affairs/DocumentationRole: Regulatory Affairs ManagerEmployment Type: Full Time, Permanent , Education:UG -B.Pharma - PharmacyPG - M.Pharma - PharmacyDoctorate - Doctorate Not Required

Keyskills :
scmsalarycontinuous improvement facilitationandaclinical researchbatch recordswriting skillspharmatechnical writingregulatory affairsemeapharmaceutical manufacturingregulatory guidelinespdrproduct developmentcontrolled environments

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