Regulatory Affairs Manager Emerging or ROW Markets (Pharma)

Archerchem Healthcare

8 - 13 years

6 - 14 Lacs

mumbai mumbai suburban mumbai (all areas)

Posted:2 hours ago| Platform:

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Skills Required

dossier compilation regulatory affairs row market regulatory compliance emerging markets drug regulatory affairs regulatory guidelines compliance dossier preparation submission compliance management ectd regulatory submissions ctd latam dossier

Work Mode

Work from Office

Job Type

Full Time

Job Description

Regulatory Affairs Manager

Key Responsibilities

Manage
regulatory submissions, approvals, and renewals
for Emerging & ROW markets (Asia, Africa, Latin America, CIS, Middle East, etc.).
Prepare, review, and compile
CTD / ACTD dossiers
for new product registrations.
Coordinate with
R&D, QA, QC, and Production teams
to gather technical data and ensure dossier readiness.
Maintain and update the
registration database and product life-cycle documentation
.
Handle
query responses
and communicate with overseas partners, distributors, and regulatory agencies.
Ensure
timely renewal, variation filing, and post-approval changes
as per local market requirements.
Keep track of
country-specific regulatory guidelines
and updates for compliance.
Support
regulatory audits and inspections
as needed.
Provide regulatory input during
new product development and launch planning
.

Desired Candidate Profile

Graduate / Post-Graduate in
Pharmacy or Life Sciences
.
715 years of experience
in
Regulatory Affairs
within a
pharmaceutical formulation company
.
Hands-on experience in
dossier compilation and submission
for Emerging & ROW markets.
Strong understanding of
CTD/ACTD and ECTD formats, stability data, and technical documentation
.
Excellent communication, coordination, and documentation skills.
Experience with
export markets and regulatory communication
preferred

Perks and Benefits

Opportunity to work with a globally expanding pharmaceutical organization.
Exposure to multi-country regulatory environments.
Competitive compensation and growth prospects.

Location - Malad - Mumbai

Interested candidate pls mail me your cv on hr@archerchem.com or WhatsApp at 9028871352.

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