Regulatory Affairs Pharmacist

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Irfa******

  • Malaysia 
  • Last Update: 13.12.2018 at 12:00

Job Type
Full Time
Start
ASAP
Duration
11 Month +
Place
Kuala Lumpur, MY
Country
Malaysia

Category


Clinical and medical development

Description


Job Description
  • Implement regulatory strategies to ensure that all new products are filed and approved within optimum timeline
  • Ensure that all regulatory maintenance activities (LPC, CMC variations, artworks, renewals, import license and etc) are filed and approved in timely manner for compliance and to support commercial supply
  • Maintain good regulatory affairs documentation and tracking
  • Handle variations of pharmaceutical product submission
  • Ensure that GDPMD regulatory compliance system is established, implemented and maintained
The Successful Applicant
  • Bachelor's Degree in Pharmacy/Pharmacology
  • Registered Pharmacist with the Pharmacy Board of Malaysia
  • At least 2 years of experience in Regulatory Affairs
  • Good communication skills
  • Flexible and agile
  • High attention to details

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