Regulatory Affairs
Regulatory Affairs
Posted on :
24-08-2025
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1 Vacancy
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Job Description
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.
- Productwise 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.
Employment Type
Full Time
Key Skills
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