Regulatory Affairs Executive / Senior Executive (ROW Market)

Jodas Expoim

2 - 7 years

0 - 2 Lacs

hyderabad

Posted:3 days ago| Platform:

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Skills Required

dossier preparation cmc documentation regulatory affairs ctd/ectd compilation injectable formulations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Prepare, compile, and review
dossiers (CTD/eCTD format)
for
ROW markets
covering
Modules 3-5
.
Support in preparation and submission of
Modules 1-2
(Administrative and Summaries) as per regulatory guidelines.
Ensure that dossier submissions comply with the respective
country-specific regulatory requirements
.
Coordinate with cross-functional teams
R&D, QA, QC, Manufacturing, and Packaging
to gather required documents and technical data.
Review and ensure correctness and consistency of
CMC (Chemistry, Manufacturing & Controls)
documentation for injectable products.
Support
variations, renewals, and post-approval changes
for ROW regulatory filings.
Maintain up-to-date knowledge of
ROW regulatory guidelines
(e.g., LATAM, ASEAN, Africa, CIS, MENA).
Track submission and approval status, maintaining regulatory databases and documentation.
Assist in responding to
regulatory queries or deficiencies
from health authorities.
Participate in internal audits and support regulatory compliance activities.

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