Walk in for Executive / Senior Executive Regulatory Affairs (US Market)
Experience : 3 to 15years
Qualification : M. Pharm/ M.Sc
Roles and Responsibilities :
The compilation of ANDAs, and ensure for timely submission to USFDA. Preferred for Solidoral / Topical / Gel.
The assessment for outsourced DMFs
Review of Technical documents received from manufacturing site such as development reports, BMR, BPR, specifications, method validation, process validation, change control etc.
Coordinating with R&D, QA, Production, ADL and Purchase for collection of Technical data for the compilation as per the guidelines
To ensure timely response of deficiencies raised by Agency on ANDA’s
Handling of Change Controls and deviations for their impact on respective regulatory submission.
Review, compilation and authoring of CMC, Bio Pharmaceutics, Labeling, Module 1 documents.
Authoring and review of ANDA dossier/deficiencies in eCTD format.
Time and venue :
18th Dec, 2021
10.00 AM – 3.00 PM
Alkem Laboratories Ltd (R&D), C-6/1 C-6/2 C-17/7, Dist, Industrial Estate, Opposite Taloja Police Station,Taloja, Navi Mumbai, Maharashtra 410208
Contact – Snehal Parkhi (HRD)
All the candidates interested to attend walk in are requested to take adequate COVID protection measures as per the government norms.
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