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Alkem Laboratories Ltd.
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Sr. Officer - DRA US MKT

Sr. Officer - DRA US MKT

Alkem Laboratories Ltd.

5 - 9 years

0 Lacs

navi mumbai maharashtra

Posted:1 week ago| Platform: Shine logo

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Skills Required

review authoring compilation spl publishing validation regulatory support ectd submission pader annual report submission pas submission

Work Mode

On-site

Job Type

Full Time

Job Description

As a Regulatory Affairs Specialist in our company, your role will involve the following key responsibilities: - Ensuring timely response to deficiencies raised by Agency on ANDAs. - Reviewing all specifications and proposals from sites of approved ANDAs for supplement filings. - Providing regulatory support and reviewing pre-filing and development documentation such as development reports, BMR, BPR, specifications, method validation, process validation, change control, etc. - Authoring, compiling, and reviewing ANDA dossier in eCTD format and structured product labeling (SPL), followed by publishing, validation, and submission of the dossier. - Submitting PADER to comply with USFDA requirements for approved ANDAs. - Reviewing all supporting data for Annual report submission within the reporting period as per USFDA requirements. - Submitting PAS for alternate vendor development activity. No additional details of the company are mentioned in the job description.,

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Sr. Officer - DRA US MKT