Junior Regulatory Affairs, Quality Assurance

2 weeks ago

Kuala Lumpur, Malaysia Agensi Pekerjaan Permit Pro Consultancy Sdn Bhd Full time

**Job Summary**:
As a Junior Regulatory Affairs, Quality Assurance & Compliance Executive, you will play a crucial role in supporting regulatory processes, ensuring compliance, and maintaining product quality within the specified regions of Malaysia, Philippines, Vietnam, Singapore, Cambodia, Laos, and Myanmar. This role involves assisting with product registrations, and regulatory submissions, and liaising with authorities to ensure adherence to local health regulations.
- Assist in managing product registration, maintenance, and regulatory file maintenance in the specified regions. Support new product registration activities, including preparing and reviewing product dossiers, classifications, labeling, and pre-submission compilations.
- Assist as a liaison with government regulatory agencies and the Ministry of Health. Participate in regulatory technical advisory boards and industry association meetings. Coordinate and monitor regulatory submissions, especially for lab testing in the specified regions. Collaborate with Regulatory Affairs personnel and overseas authorities to facilitate smooth registration processes. Ensure prompt and effective communication internally and externally with stakeholders. Assist in maintaining proper filing and storage of regulatory documents for easy retrieval.Contribute to keeping the product database up to date.
- Assist in managing regulatory implications among the seven regions and supporting regulatory planning. Contribute to maintaining up-to-date Health Supplement regulations and guidelines in the RA database.
- Support in outlining requirement checklists for Health Supplement registration in the specified regions. Assist in reviewing and approving Ads and promo materials to ensure compliance with local regulations. Assist in following up on Corrective and Preventive Actions (CAPA) to meet required methods and timelines. Contribute to ensuring the Quality Management of Distributors per request. Support internal/external QA-relevant auditing. Assist in maintaining or ensuring QA documentation is in place. Undertake other tasks as assigned.

**Job Requirements, Qualifications & Skills**:

- Bachelor's degree in a relevant field (e.g., Regulatory Affairs, Quality Assurance, Pharmacy, Life Sciences).
- **1 - 2 years** **of experience in regulatory affairs, quality assurance, or a related field is desirable.**:

- Basic understanding of regulatory requirements in the specified regions.
- Strong organizational and multitasking skills.
- Excellent communication and interpersonal skills.

**Salary**: RM2,500.00 - RM3,000.00 per month

Schedule:

- Monday to Friday

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