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, Pharmacovigilance, and Manufacturing teams.
Ensure dossier compliance with
WHO, ICH, and local authority guidelines
.
2. Regulatory Strategy & Market Support
Develop
registration strategies
for RoW markets considering country‑specific regulations.
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.
5. Compliance & Intelligence
Monitor
regulatory guideline updates
for RoW markets.
Ensure submissions comply with the
latest country requirements
.
Support internal audits, regulatory inspections, and due‑diligence audits.
6. Team & Project Coordination
Mentor junior team members and review their regulatory work.
Track regulatory milestones and ensure alignment with project timelines.
Participate in cross‑functional meetings for project planning and risk assessment.
Markets Typically Covered (RoW)
LATAM
: Brazil, Mexico, Colombia, Peru, Chile, Guatemala
MENA/GCC region
CIS
: Russia, Ukraine, Kazakhstan,etc.
ASEAN
: Philippines, Vietnam, Thailand, Malaysia