Sr. Officer - DRA US MKT

Alkem Laboratories Ltd.

0 years

0 Lacs

navi mumbai maharashtra india

Posted:3 weeks ago| Platform:

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Skills Required

dra support development documentation reports labeling spl publishing data report reporting

Work Mode

On-site

Job Type

Full Time

Job Description

To ensure timely response of deficiencies raised by Agency on ANDA’s.
Review for all specifications and proposal from sites of approved ANDAs for supplement filings.
Regulatory Support and review for pre-filing and development documentation such as development reports, BMR, BPR, specifications, method validation, process validation, change control etc.
Authoring, compilation and review of ANDA dossier in eCTD format and structured product labeling (SPL), followed by publishing, validation and submission of dossier.
PADER submission to comply with USFDA requirement for approved ANDA.
Review of all the supporting data for Annual report submission within reporting period as per USFDA requirement.
PAS submission for alternate vendor development activity

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