Posted:4 days ago|
Platform:
On-site
Full Time
DRA Profile – Please find below the job description as requested.
o Preparation of Dossier as per country guidelines (ACTD/CTD & Country Specific format).
o Preparation of SmPC, PIL & Package insert as per country specific requirements.
o To review all documents related to dossier preparation such as Quality and administrative documents.
o To manage new registration/re-registration/query/variation filing, etc.
o Handling and resolving queries raised by MOH/Customers within deadline.
o Ensuring that quality standards are met and submissions of dossiers meet strict deadlines.
o Reviewing labeling and labels for compliance with regulatory requirements.
o Artworks for dossier preparation.
o Working on Pre & Post registration of dossier registration.
o To make a technical file for registered dossier
o To coordinate with various departments such as quality assurance, production, quality control.
o Work on lifecycle management for compilation and record of all regulatory documents
Job Type: Full-time
Pay: ₹24,000.00 - ₹25,000.00 per month
Work Location: In person
Harasha Pharma Pvt ltd
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