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Regulatory Affairs Associate

0-3 Years
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  • Posted a month ago
  • Over 100 applicants
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Job Description

  • Prepare, review, and submit amendments and supplements for the assigned products.
  • Prepare summary documents for regulatory submission.
  • Prepare, review, and submit responses to the Agency s queries for the assigned products.
  • Compile and submit Global Annual Reports.
  • Review stability protocols and reports, analytical method validation protocols, and reports.
  • Review raw material, packaging material, finished product specifications, finished product stability specifications, and testing procedures.
  • Review batch records.
  • Review Process Validation Protocol, hold time study protocols, and reports.
  • Review Product Development Report.
  • Review executed documents, including executed BMR, Certificate of Analysis, to ensure compliance with regulatory requirements.

More Info

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Industry:
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Open to candidates from:
Indian

About Company

Thepharmadaily is the best Pharma training institute located in India, exclusively designed and fabricated for Pharmacy undergraduates & postgraduates. ThePharmadaily is here to provide Classroom training, 100% Placement assistance, Talk shows with Industry experts, interaction with experienced professionals, and real-time corporate life experiences. Thepharmadaily provides a variety of trainings like Pharmacovigilance, clinical data management, medical coding, medical writing, narrative writing, HEOR, and medical underwritting.

Job ID: 123776027