Executive-regulatory Affairs

1 week ago

Klang, Malaysia Bodibasixs Manufacturing Sdn Bhd Full time

**Key Responsibilities**

**1. Integrated Management Systems (IMS) Compliance**
- Support the management of the company’s IMS covering:

- ISO 9001 (QMS)
- ISO 22716 (Cosmetic GMP)
- Halal (Malaysia & Indonesia)
- RSPO
- ISO 14001 (EMS)
- ISO 45001 (OHS)
- Maintain and update controlled documentation (Policies, SOPs, Work Instructions, Forms) related to all IMS functions.

**2. Documentation & Audit Support**
- Prepare, control, and update all IMS records and reports.
- Coordinate and participate in internal & external audits, regulatory inspections, and certification audits.
- Manage CAPA (Corrective and Preventive Actions) and ensure closure of non-conformities.
- Assist in audit planning, execution, and post-audit documentation.

**3. Regulatory Affairs & Product Compliance**
- Handle product notification, registration, and Halal certification submissions for Malaysia and Indonesia.
- Maintain and update Product Information Files (PIFs), dossiers, and regulatory records.
- Review product labels, packaging, and marketing materials to ensure regulatory compliance.

**4. Quality, Environmental, and Occupational Health & Safety (QESH)**
- Support the development and implementation of QESH programs under ISO 14001 and ISO 45001.
- Coordinate activities with the ESH Committee and support safety, health, and environmental reporting.
- Ensure compliance with internal ESH protocols and regulatory requirements.

**5. Training & Awareness**
- Conduct training sessions and awareness programs on Halal, GMP, ISO standards, and other IMS-related topics for internal stakeholders.

**6. Ad-Hoc Responsibilities**
- Undertake other tasks and developmental projects as assigned by the Head of Department - Regulatory Affairs.

**Requirements**:

- Bachelor’s Degree in Science, Pharmacy, Chemistry, Biotechnology, or a related field.
- Minimum 2-3 years of experience in Regulatory Affairs, Quality Assurance, or Compliance (preferably in cosmetics, personal care, or pharmaceutical industry).
- Familiar with local and international regulations including NPRA, BPOM (Indonesia), Halal JAKIM, and relevant ISO standards.
- Strong documentation, organizational, and communication skills.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
- Ability to work independently and collaboratively in a fast-paced environment.
- Strong attention to detail and a commitment to continuous improvement.

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

Pay: RM3,000.00 - RM4,000.00 per month

**Benefits**:

- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development

Schedule:

- Monday to Friday

Supplemental Pay:

- Overtime pay
- Performance bonus

**Education**:

- Bachelor's (preferred)

Work Location: In person

Expected Start Date: 08/11/2025

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