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Regulatory Affairs Associate (Drugs & Cosmetics)

RM 2,500 - RM 3,500 / month

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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.

Job Type: Full-time

Pay: RM2,500.00 - RM3,500.00 per month

Schedule:

  • Monday to Friday