Regulatory Affairs Associate
1 week ago
**Roles and Responsibilities**
- Support regulatory compliance advisors in Therapeutic & Health Products, projects.
Projects activities include:
1. Reviewing product technical documentation or technical file preparation on therapeutic and health products.
2. Product registration with country dossier preparation from the product technical documentation & Quality Management system for Malaysia NPRA, and global regulatory authorities.
- Support company administrative activities assigned to team related to health products business.
- Support in projects by understanding client needs, strategy planning, preparation of required documents or sourcing of information, tracking of status and communication to client for timely completion of projects.
- Support business process documentation preparation and implementation, e.g., Confidential Disclosure Agreement.
**Requirements/Qualifications**
- Diploma or Degree of Pharmacy or a relevant field.
- Good understanding and knowledgeable in regulatory & quality standards for medical device and health products.
- Prior experience in regulatory requirements of drugs, health supplements or cosmetic is preferred.
- Demonstrated track record of collaborative, detail-oriented project management skills.
- Excellent English-speaking & writing skills, and good interpersonal skills.
**Salary**: RM2,500.00 - RM3,500.00 per month
Schedule:
- Monday to Friday
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