ACG Capsules (Thailand) Co., Ltd. is a manufacturer of empty hard gelatin capsules used for pharmaceutical productsboth modern and traditional medicine (herbal)as well as dietary supplements.
The New setup Manufacturing Facility in Thailand is located in WHA Rayong Nonglalok Sub district, Bankhai District, Rayong.
We are hiring Regulatory Affairs Position in the Quality Department.
Job Objective
- Provide regulatory support to customers in order to meet current and new regulatory norms.
- Life cycle management of existing dossier in various countries to meet customer and regulatory norms.
Strategic and planning
Functional
Core Responsibilities:
- Ensure compliance with all regulatory norms (both new and existing).
- Prepare and submit Drug Master Files (DMFs) in CTD format for respective regions on an annual and biannual basis, including issuance of Letters of Authorization (LOA).
- Handle customer questionnaires and specifications promptly.
- Respond to customer and regulatory queries within predefined timelines.
- Conduct regulatory checks of shades and artwork.
- Obtain and renew regulatory certificates in a timely manner.
- Generate and maintain regulatory backup data to effectively respond to regulatory and customer queries.
- Prepare and maintain regulatory documentation for both existing and new products.
- Provide change notifications to customers as required.
- Provide regulatory support to Plant QA and International RA teams as needed.
- Verify regulatory acceptance of various ingredients across different countries for existing and new products.
- Maintain and update data in internal online systems.
- Maintain and improve the Quality Management System (QMS) in compliance with applicable standards.
- Participate in internal audits, supplier audits, and support external inspections.
- Support CAPA, non-conformances, deviation management, and change control processes.
- Assist with batch release, documentation control, and product quality reviews.
- Manage training programs and ensure QA compliance across departments.
Internal Process:
- Publish regulatory updates to raise awareness among internal stakeholders.
People development
- Train CSR team and Plant associates (if required) on regulatory requirements
Qualifications
- Bachelor's or Master's degree in Phamacy, Pharmaceutical Science, Chemistry, Biotechnology or related to.
- Experience in Regulator Affaris minimum 3-5 years.
- Background from Pharmaceutical / Food Supplement / Nutraceutical / Herbal / Medical Device Chemical / Biotech / Life Science / Cosmetics / API / Raw Material Manufacturing.
- English Communicable is a must.
- Be able to base in Rayong, BanKhai (WHA Rayong).
