Regulatory Affairs Associate

Responsibilities:

• Responsible for all regulatory affairs, regulatory compliance activities & submission of drug & medical device of the Company
• Gain and maintain optimal regulatory approvals in a timely manner and in compliance with relevant regulations
• Review and update information, labels and other documentation as required for regulatory compliance
• Maintain and track the registration status of all marketed products
• Provide regulatory inputs and support for marketing plans, product registration and variations to the marketed products
• Maintenance of Standard Operations Procedures
• In charge of all other Company’s regulatory issues

Requirements:

• Diploma or Degree in Pharmacy, Biotechnology or Science
• Minimum 1-year relevant working experience
• Good command of English and Mandarin in both written and verbal is a must for this position.
• Possess keen interest in regulatory work
• Expertise for the Malaysia regulatory issues preferred
• Pleasant, positive, meticulous and independent worker who is able to multi-task
• Computer literacy
• Able to handle administrative duties with good document organization skills
• Candidate who is registered with the Pharmacy Board of Malaysia and eligible to apply for Poison License Type A would been an added advantage
• Pharmacists with no prior regulatory experience are encourage to apply.
• Fully vaccinated with covid-19.