Regulatory Affairs Executive

Noronic Pharmaceutical Pvt Ltd

5 years

0 Lacs

ahmedabad gujarat india

Posted:8 hours ago| Platform:

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Skills Required

stability reports maintenance development packaging labeling compliance coordination qc data documentation communication

Work Mode

On-site

Job Type

Full Time

Job Description

Company Description

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Key Responsibilities:

Preparation and submission of
legal documents
required for product registration and licensing.
Preparation and application for
Product Permissions
,
FSC (Free Sale Certificate)
, and
COPP (Certificate of Pharmaceutical Product)
.
Handling
Process Validation (PV)
,
Stability Studies
,
Process Validation Reports (PVR)
,
Analytical Method Validation (AMV)
, and
Bioequivalence (BE) Studies
documentation.
Preparation and maintenance of
PDR,Product Dossiers
,
Product Development Files (PDF)
, and
Summary of Product Characteristics (SmPC)
.
Review and approval of
artwork
, packaging materials, and labeling to ensure compliance with regulatory requirements.
Coordination with QA, QC, Production, and R&D departments for regulatory data compilation.
Keeping updated with current regulatory guidelines and ensuring product compliance for domestic and international markets.

Requirements:

Bachelor’s or Master’s degree in Pharmacy or related field.

Regulatory Affairs

WHO, ICH, and country-specific guidelines

Excellent documentation, communication, and coordinate

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