Protege - Regulatory Affairs & Pharmacovigilance

1. Surveillance (Internal and Post-Market)
- Assist in checking all artwork of existing registered products and to ensure all information in the artwork are as per registered information and comply with the registration requirement.
- Assist to coordinate, verify, and ensure that the documents in the product file (technical specification, certificate of analysis, batch manufacturing record, packaging material etc.) is up-to-date.

2. Product Complaint
- Assist in managing operation of the product complaint management system
- Upon received the product complaint from regulatory authorities or related entity for tender product (e.g., logistics and distribution concession entity i.e., Pharmaniaga):
- To acknowledge receipt of complaint to regulatory authorities or related entity
- To notify respective manufacturer /principal/supply chain management team for investigation accordingly
- Assist in review, prepare and submit the investigation report upon received from manufacturer / principal

3. Amendments to particulars of a registered product
- Variation (inclusive Change of Product Registration Holder (COH) and Change of Manufacturing Site (COS)) etc.
- Assist in notifying regulatory authority on any changes or amendments of registered products progressively and timely
- Assist in review and ensure variation documents received from relevant stakeholders are accordance to current variation requirements
- Assist to liaise with other unit, department and manufacturer should additional information require for variation submission and during variation evaluation, as and when necessary
- Assist to follow-through and monitor the variation evaluation and approval of products submitted to regulatory authority and to tackle any queries or problems arise as and when necessary

4. Product Registration File and Product List
- Assist to maintain and keep Product Registration Files for all products up to-date by ensuring all relevant documents (e.g., correspondence remarks and communications from and to regulatory authority, quality data such as stability studies, batch manufacturing records etc.) are filed accordingly for each product.
- Assist to update Product List related to respective manufacturer/principal assigned.
- Assist to prepare report on the registration status and update relevant stakeholders (manufacturer/principal, relevant divisions or departments) accordingly.

5. Pharmacovigilance
- Assist and provide support in the management of all pharmacovigilance activities conducted by the organization in compliance with regulatory requirements and timelines.

6. Regulatory Updates
- Keep abreast of current registration requirements and update plants or relevant divisions or departments accordingly.

7. Administrative
- Support administrative matters of pertaining to the department activities.

8. Others
- Compliance with Good Distribution Practice for Medical Devices (GDPMD) under Act 737 2012
- Undertake any other duties as directed by the Immediate Supervisor and Management as and when required.

**Job Type**: Fresh graduate

Pay: RM2,000.00 per month

**Benefits**:

- Opportunities for promotion
- Professional development

Schedule:

- Monday to Friday

Supplemental Pay:

- Overtime pay

Application Question(s):

- Fresh graduate or has working experience?

**Education**:

- Bachelor's (preferred)

Willingness to travel:

- 100% (preferred)

Application Deadline: 12/31/2024
Expected Start Date: 01/02/2025