Key Responsibilities
1. Dossier Preparation & Submissions
Prepare, review, and submit
CTD / ACTD / country‑specific dossiers
for:
New product registrations
Line extensions (strength, pack size, shelf life)
Variations and renewals
Coordinate compilation of
Modules 1–5
with QA, QC, R&D, CMC, PV, PM, and Manufacturing teams.
Ensure dossier compliance with
WHO, ICH, and local authority guidelines
.
2. Regulatory Strategy & Market Support
Support
business development
by providing regulatory feasibility and timelines for new markets/products.
Assess regulatory impact for formulation/site changes.
3. Regulatory Lifecycle Management
Manage
post‑approval changes
, including:
CMC variations
Labeling updates
Artwork changes
Track and ensure
timely renewals/re‑registrations
.
Maintain approved product documentation and regulatory databases.
4. Health Authority Interaction
Handle
deficiency letters / queries
from regulatory agencies.
Prepare responses in coordination with internal stakeholders.
Liaise with
local agents, consultants, and partners
for RoW countries whenever required.
5. Compliance & Intelligence
Monitor
regulatory guideline updates
for RoW markets.
Ensure submissions comply with the
latest country requirements
.
Markets Typically Covered (RoW)
LATAM
: Brazil, Mexico, Colombia, Peru, Chile, Guatemala
MENA/GCC region
CIS
: Russia, Ukraine, Kazakhstan, etc.
ASEAN
: Philippines, Vietnam, Thailand, Malaysia, etc.