Senior Regulatory Affairs Specialist

We’re looking for a Senior Regulatory Affairs Specialist for our growing organization.

Overview

Tasks and responsibilities :

Responsibilities

• Plan and manage the regulatory affairs activities for assigned product portfolio.
• Prepare product related submissions according to regulatory requirements and submit required documentation / information to local authorities.
• Archive the electronic and hard copy documentation on time and properly.
• Update and maintain the product registration database.
• Coordinate the post market activities including translations, notification to Authorities, timely distribution of customers letters and achievement of the required response rate.
• Check product artwork and ensure it is up to date.
• Follow up the announcements, notifications, circulars and regulations published by official authorities to ensure that necessary actions are taken.
• Ensure compliance with the relevant local directives and related regulations in place.

Qualifications and experience

Seniority level

Employment type

Job function

Industries

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