Akums Drugs & Pharma Recruitment Officer- DRA Regulatory filing strategy evaluation for Domestic Market
Author
high-quality CMC documentation for domestic submission, with support and
guidance, applying agreed CMC domestic regulatory strategies, assuring
technical congruency and regulatory compliance, meeting agreed upon timelines
throughout project lifecycle.
Preparing CMC
responses to health authority questions during development, registration and
product lifecycle.
Identification
of required documentation for domestic submissions and negotiate the delivery
of approved technical source documents in accordance with project timelines.
Identification
of content, quality and/or timeliness issues with source documents, or any
other potential authoring issues that may impact submission quality or
timelines, as early as possible.
Keep updates
with regard to regulatory guidelines and requirements in all global regions as
well as for new technical trends.
Preparation
of various application Documents (Covering letter, Various application, medical
rationale, executive summary for SEC referral For filing of FDC applications.
Preparation
of Import License Application.
Address;AKUMS
DRUGS & PHARMACEUTICALS LTD., 301-305, MOHAN PLACE, L.S.C, BLOCK-C
SARASWATI, VIHAR, DELHI-34, NEW DELHI, Delhi, India.
Contact: Ms.
Nikita Sehgal,
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