Executive – Regulatory Affairs

Svizera Health Remedies

2 - 4 years

3 - 5 Lacs

mumbai

Posted:1 month ago| Platform:

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Skills Required

regulatory affairs qa qc fda regulatory intelligence ema cdsco

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Summary:

Executive Regulatory Affairs

regulatory guidelines, documentation practices, and submission processes

Key Responsibilities:

Prepare, compile, and review
regulatory documents and dossiers
for submission to national and international health authorities.
Ensure
timely submission, approval, and renewal
of product registrations, licenses, and certificates.
Maintain
regulatory databases, tracking systems, and documentation
for all assigned products.
Support
new product launches, variations, and post-approval changes
by coordinating with cross-functional teams (QA, QC, R&D, Production).
Review and approve
product labeling, artwork, and promotional materials
for regulatory compliance.
Keep abreast of
latest regulatory requirements, notifications, and updates
from relevant authorities (CDSCO, FDA, EMA, WHO, etc.).
Coordinate with
regulatory agencies, consultants, and partners
for submissions and clarifications.
Participate in
audits and inspections
, providing required documentation and responses.
Ensure compliance with
Good Regulatory Practices (GRP)
and company SOPs.
Support
regulatory intelligence activities
and contribute to process improvements.

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