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Regulatory Affairs Executive

Last update 2024-06-15
Expires 2024-06-14
ID #2187040663
Regulatory Affairs Executive
India, Andhra Pradesh, Hyderabad,
Modified June 9, 2024


RA US injectable JD:

Knowledge on manufacture and testing of sterile products and Knowledge of environmental conditions during sterile product manufacturing.
Review and clearance of pre-exhibit batch R&D documents like formula clearance w.r.t Q1/Q2, IIG, specifications/STP of Raw materials, packaging, in-process and finished product inline with ICH and USP.
Review Compilation and submission ANDAs (generic andnew drug applications) to US FDA.
Follow up with CFTs for complement of action items for deficiencies comments and prepare clear responses to each comment.
Life cycle management of approved drug products including CBE-30, PAS and annual reports.
Compilation and/or review of sterility assurance validation summaries required for original and post approval submissions

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Regulatory affairs executive

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