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Job Location | Hyderabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | General / Other Software |
EmploymentType | Full-time |
Roles and Responsibilities Dear Professional, Greetings! We have opportunity for RA (Injectable) professionals at Hyderabad Location. Should have experience in ANDA Filing. Qualification - M.Pharm with 3 To 7 Years. Role - RA Specialist (Injectable) 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 If you are keen kindly revert with your updated CV along with CTC,ECTC and Notice period to saritha@bvrpc.com Salary: Not Disclosed by RecruiterIndustry: Pharma , Biotech , Clinical Research Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology Role Category: Drug Regulatory Affairs/DocumentationRole: Drug Regulatory DirectorEmployment Type: Full Time, Permanent ,
Keyskills :
pharmabatch recordspdrfilingpackingresearchproduct developmentclinical researchcontinuous improvement facilitationlabelsandaclinicalscmtestingrecordsmedical