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Regulatory Affairs

3 months ago

Subang Jaya, Selangor, Malaysia United Italian Trading (M) Sdn Bhd Full time

Positions:

a) Pharmacist

b) Regulatory Affairs Manager

c) Regulatory Affairs Assistant Manager

d) Regulatory Affairs Senior Executive

e) Regulatory Affairs Junior Executive

Responsibilities:

  • Responsible for all regulatory affairs, regulatory compliance activities, and submission of pharmaceutical and medical device products of the Company.
  • Liaise with regulatory bodies such as the NPRA, MDA, and vendor's regulatory personnel to ensure all information, labels, and other documentation comply with relevant regulations.
  • Work closely with the Notified Body to approve Change notifications for medical devices
  • Participate in company regulatory and quality audits when required.
  • Monitor and supervise the regulatory status of all company products.
  • Assist in executing field corrective actions/recalls/reports of medical devices malfunctions and adverse events.
  • Stay updated on new and existing regulations.
  • Carry out other regulatory tasks as assigned by the Management.

Requirements:

  • Must be a Registered Member with the Malaysian Pharmacy Board.
  • 12 years of working experience
  • Proficient in written and spoken English and Bahasa Melayu. Chinese optional
  • Excellent problemsolving skills and the ability to work independently.
  • Good communication skills and computer literacy.
  • Responsible and selfmotivated.
  • 5 working days per week (Monday Friday) from 8.45am to 5pm
  • We welcome fresh graduates without experience.
  • Retired pharmacists who are members of the Malaysian Pharmacy Board are encouraged to apply.