Executive, Regulatory Affairs

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

.

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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.

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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.

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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.

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5. Compliance & Intelligence

• Monitor

regulatory guideline updates

for RoW markets.

• Ensure submissions comply with the

latest country requirements

.

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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.

Required Qualifications & Experience

• Educational Background:
  o M.Pharm / B.Pharm
• Experience:
  o 3-9 years in Pharmaceutical Regulatory Affairs