REGULATORY AFFAIRS-EXECUTIVE/SR.EXECUTIVE-EXPERIENCED

From 2 to 7 year(s) of experience

 ₹ Not Disclosed by Recruiter

Hyderabad/Secunderabad

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Job Description

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Department: Regulatory Affairs

Industry: Pharma Only

Qualification :M.Pharma/B.Pharma

Experience:2 to 8 Years

CTC: Negotiable

Roles and Responsibilities

• Review and Preparation of ANDA as per FDA Guidelines
• Submitting dossiers in e-CTD format using Pharmaready software
• Review of CMC Documents from plant
• Review of R&D Documents
• Preparing response and arranging required documents for queries from USFDA (IR , CR and DRL)
• ICH and FDA guidelines

• Knowledge about requirements for the ACTD and CTD Dossiers.
• Compilation and review of dossiers for various countries like LATAM, CIS and Middle east etc.
• Reviewing the technical documents provided by QA, QC & Production departments and them the report of shortcomings & ensure them to correct.
• Preparation of packaging materials and patient information leaflets and Smpc
• Technical Documents review like specifications, STPs, BMRs, Stability Studies, Process validation, Artwork, SmPC and DMF.

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M.Pharma/B.Pharma