Regulatory Affairs Associate (Drugs & Cosmetics)
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