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FDC Limited
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Executive - Regulatory Affairs (ROW)

Executive - Regulatory Affairs (ROW)

4 - 9 years

|

4 - 9 Lacs

Posted:10 hours ago| Platform:

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Skills Required

row markets dossier preparation documentation product registration regulatory affairs drug regulatory affairs compliance. pharma regulatory export registration non-regulated market moh queries tender documentation semi-regulated market regulatory compliance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Executive Regulatory Affairs (ROW)

Key Responsibilities:

Prepare and compile regulatory dossiers for semi-regulated and non-regulated markets (ROW).
Respond to queries and deficiencies raised by the Ministry of Health (MOH) or buyers related to dossiers and submissions.
Coordinate the arrangement and dispatch of product samples, working standards, and other materials required for registration.
Gather and organize documentation required for tenders and complete relevant questionnaires accurately.
Liaise with manufacturing plants and cross-functional departments to obtain documents, samples, and data necessary for registration and submissions.
Support the Section Head in generating regulatory data and documentation as required by the Exports Department.
Ensure compliance with applicable international regulatory standards and maintain up-to-date knowledge of evolving global requirements.

Key Skills & Competencies:

Strong understanding of regulatory requirements for semi-regulated and non-regulated markets.
Excellent documentation, coordination, and communication skills.
Proficiency in dossier preparation, query handling, and submission tracking.
Ability to work collaboratively across departments and manage multiple projects simultaneously.
Attention to detail and strong organizational abilities.

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Executive - Regulatory Affairs (ROW)

mumbai

INR 4 - 9 Lacs

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