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Regulatory affairs

  • Work as Senior GRA Labeling Specialist at Sanofi

    Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for marketed and LCM products
  • Site Start Up EUCTR II Specialist Post at PAREXEL
    Site Start Up EUCTR II Specialist Post at PAREXEL
    Triage and manage Requests for Information (RFI) from regulatory authorities, coordinating responses with relevant stakeholders. Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submissions and ensure compliance with country requirements
  • Amneal Pharmaceuticals Hiring Regulatory Affairs Executive
    Amneal Pharmaceuticals Hiring Regulatory Affairs Executive
    Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines. Exposure of the Sterile dosage form / complex injectable dosage form and brief manufacturing process and key regulatory aspects. Amneal Pharmaceuticals. Qualification : B.Pharm, M.Pharm
  • Sandoz Require Regulatory Affairs Specialist
    Sandoz Require Regulatory Affairs Specialist
    Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Sandoz
  • Require Regulatory Affairs Manager at Medtronic
    Require Regulatory Affairs Manager at Medtronic
    Advanced degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field. Demonstrated experience supporting regulatory submissions, registrations, compliance activities, and regulatory lifecycle management. Medtronic
  • Lonza Require Regulatory Affairs Specialist
    Lonza Require Regulatory Affairs Specialist
    Write CMC regulatory dossiers for Drug Substance filing (small and Large API Molecules) using source documents, ensuring accuracy, completeness, and compliance.
  • DDReg Pharma Looking for Regulatory Affairs Trainees
    DDReg Pharma Looking for Regulatory Affairs Trainees
    Looking for motivated and detail-oriented candidates to join DDReg Pharma as RA Trainees. This role provides an opportunity for freshers to build their career in the Regulatory Affairs domain while gaining practical exposure to regulatory documentation, submissions, dossier preparation, and regulatory guidelines.
  • THSTI Recruitment Clinical Research, Life Sciences, Regulatory Affairs candidates
    THSTI Recruitment Clinical Research, Life Sciences, Regulatory Affairs candidates
    B.Tech/ M.Sc./ M.Tech degree or two years PG Diploma in Clinical Research / Clinical Research Management / Regulatory Affairs / Life Sciences or related field from a recognized University
  • Hetero Hiring Regulatory Affairs Officer / Senior Executive
    Hetero Hiring Regulatory Affairs Officer / Senior Executive
    Knowledge of China registration activities will be an added advantage for the China section. Basic knowledge of ICH Guidelines and API regulatory requirements.
  • DPSRU invites Assistant Professor and Guest Faculty
    DPSRU invites Assistant Professor and Guest Faculty
    Besides fulfilling the above qualifications, the candidate must have cleared the National Eligibility Test (NET) conducted by the UGC or the CSIR, or a similar test accredited by the UGC, like SLET/SET or who are or have been awarded a Ph. D. Degree in accordance with ihe University Grants Commission
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