Regulatory Affairs

6 months ago


Shah Alam, Malaysia Kino Biotech (M) Sdn Bhd Full time

**Job Summary**:
The Regulatory Affairs and Quality Control Executive plays a crucial role in supporting the Regulatory Affairs and Quality Control Manager in ensuring compliance with regulatory standards and maintaining high-quality product standards. This position involves active participation in product registration activities, quality control processes, and collaboration with cross-functional teams to uphold regulatory and quality objectives.

**Key Responsibilities**:

- **Regulatory Compliance**:

- Assist in interpreting and communicating regulatory requirements to internal teams.
- Support the preparation and submission of regulatory documentation to obtain and maintain product approvals for local and overseas markets.
- Stay informed about changes in local and international regulations and communicate relevant updates to the team.
- **Quality Control**:

- Conduct quality check for every in-coming batch ensuring that the products meet the company quality standards.
- Participate in investigations and resolutions of quality-related issues from customer service, warehouse, and trades
- Actively work with factories for corrective and preventive actions
- Perform 5S housekeeping at QC retained room
- **Documentation Assistance**:

- Support the preparation and maintenance of regulatory documentation, including submissions, reports, and certificates.
- Assist in maintaining accurate and up-to-date records related to quality control and regulatory compliance.
- **Audit Assistance**:

- Participate in factory audits to assess compliance with quality standards.
- Collaborate with cross-functional teams to address and implement corrective actions identified during audits.
- Assist in GDP audit and preparation of documents
- **Collaboration**:

- Work closely with cross-functional teams, including R&D, manufacturing, and supply chain, to integrate regulatory and quality considerations into processes.
- Provide support in overseas documentation preparation, including shipping documents pertaining to importation and regulatory matters.

**Qualifications and Experience**:

- Bachelor's degree in a relevant field (e.g., Food Science/ Food Technology, Quality Management, Chemistry, Biology, or related discipline).
- Minimum of 1-2 years of experience in regulatory affairs and quality control within the health & beauty sector.
- Familiarity with local and international regulatory requirements.
- Exposure to quality control procedures and systems.
- Strong organizational and communication skills.
- Able to independently as well as working as a team.

**Job Types**: Full-time, Permanent

**Salary**: RM2,500.00 - RM3,500.00 per month

**Benefits**:

- Opportunities for promotion
- Professional development

Schedule:

- Monday to Friday

Supplemental pay types:

- Overtime pay

**Language**:

- Mandarin (preferred)



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