Ra Executive

The Pharma Patashala

5 - 8 years

6 - 9 Lacs

raichur

Posted:8 hours ago| Platform:

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Skills Required

regulatory guidelines data handling dossier preparation documentation clinical trials dossier submission

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

1. Regulatory Submissions & Approvals

Prepare, compile, review, and submit
dossiers
(CTD/eCTD/ACTD formats) for product registration.
Handle
drug master files (DMFs), ANDAs, NDAs, INDs
and ensure timely submissions to health authorities.
Manage
variations, renewals, amendments, and post-approval changes
.

2. Compliance & Regulatory Guidance

Ensure products comply with
national and international regulatory guidelines
(FDA, EMA, DCGI, CDSCO, WHO, ICH, etc.).
Monitor
regulatory changes and updates
and communicate implications to management.
Provide
regulatory strategy
and support to R&D, QA, QC, and manufacturing teams.

3. Documentation & Records

Review and maintain
CMC (Chemistry, Manufacturing, and Controls) documentation
.
Maintain
regulatory records, submissions tracker, and archives
.
Prepare
product labeling, artwork, and packaging inserts
in compliance with guidelines.

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