Job Description

Our client is a leading supplier of the FMCG business.

Responsibilities

• Providing regulatory support to customers to meet current and new regulatory norms.
• Life cycle management of existing dossier in various countries to meet customer and regulatory norms.
• Ensuring compliance with all regulatory norms (new & existing).
• Preparing & submitting Drug Master files in CTD format for the respective regions on an annual & biannual basis along with the issuance of LOA.
• Handling customer questionnaires/specifications on time.
• Responding to customer / regulatory queries within pre-defined timelines.
• Conducting regulatory checks of shades & artwork.
• Obtaining/renewing regulatory certificates on time.
• Product–wise ARTG filing in Australia as per timelines and ensure FTR.
• Generating & maintaining regulatory backup data to respond to regulatory/customer queries.
• Preparing & maintaining regulatory documentation for existing and new products.
• Providing change notifications to customers as and when required.
• Checking and releasing dossier in DMS on a timely basis.
• Providing regulatory support to Plant QA and International RA teams as and when required.
• Verifying regulatory acceptance of various ingredients in various countries for existing and new products.
• Maintaining and updating data in internal online systems.
• Publication of regulatory updates to create awareness among internal stakeholders.

Qualifications

• Bachelor or degree in Science or Related.
• Experience in the Pharmaceutical / Healthcare / Beverage / Food Processing industry of at least 5 years.
• Solid in Regulatory Affairs, and QA Documentation.
• Good in English communication.
• Willing to relocate to Rayong Province.