Regulatory Affairs Executive

2 weeks ago

Shah Alam, Malaysia EON PARTNERS Full time

**REGULATORY AFFAIRS EXECUTIVE**

***

The Regulatory Executive manages product and company license renewals with government agencies and ensures compliance with local laws and regulations. The role also monitors regulatory changes and updates management to prevent business risks.

**RESPONSIBILITIES**

**1. Regulatory Affairs & Compliance**
- Prepare, review, and submit product registration documents.
- Confirm product compliance with regulations, HS codes, and tax structures.
- Create material codes in SAP after management approval.
- Maintain updated knowledge of regulations and communicate changes to management.
- Build and maintain strong relationships with regulatory authorities.
- Ensure product labels, classifications, and SDS comply with CLASS regulations.
- Manage scheduled waste and submit timely reports to authorities (e.g., CIMS, eSWIS, Feed Act, Poison Act).
- Coordinate with suppliers and manufacturers to ensure required documentation meets legal standards.
- Conduct staff training and create procedures to ensure daily regulatory compliance.
- Keep Product Master List and SDS for all active products up to date.

**2. Quality, Standards & Auditing**
- Act as an Internal Auditor.
- Ensure regulatory practices align with EHS standards and procedures.
- Develop and implement work processes to meet compliance requirements.

**3. Inventory Planning and Management**

**4. Management Information System**
- Create and maintain product data in SAP and ensure all documentation is accurate and traceable.

**5. Managerial / Supervisory Responsibility**
- No direct subordinates, but responsible for training and guiding others on compliance matters when needed.

**6. EHS and Housekeeping**
- Comply with all EHS legal requirements, procedures, and work instructions.
- Support the company’s EHS activities through assigned responsibilities.

**SECONDARY ROLE / FUNCTION**
- Perform any additional tasks assigned by the immediate superior.

**AUTHORITY**
- Operate within company policies and Delegation of Authority guidelines.

**QUALIFICATIONS**
- Degree in Pharmacy, Chemistry, or equivalent.
- ISO Awareness and ISO Internal Auditor certification.

**EXPERIENCE**
- 2-3 years in the chemical or distribution industry.
- Familiarity with QEHS systems (e.g., ISO 9001, 14001, 18001).
- Knowledge of DG regulations, SDS, GHS, REACH, SVHC, and ROHS.
- Strong in communication, organization, problem-solving, and Microsoft Office.
- Able to work under pressure with mínimal supervision.

**Job Type**: Permanent

Pay: RM4,000.00 - RM6,000.00 per month

**Benefits**:

- Dental insurance
- Flexible schedule
- Health insurance
- Maternity leave
- Opportunities for promotion
- Parental leave
- Professional development
- Vision insurance

Schedule:

- Monday to Friday

Supplemental Pay:

- Yearly bonus

Application Question(s):

- Are your from pharmaceutical industry?
- Are you a Certified pharmacist?

**Education**:

- Bachelor's (preferred)

**Experience**:

- NPRA product registration: 1 year (preferred)

Work Location: In person

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