Regulatory Affairs Associate

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Irfa******

  • Malaysia 
  • Last Update: 29.01.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
11 Month +
Place
Petaling Jaya, Selangor, Malaysia
Country
Malaysia

Category


Regulatory, Quality, and Clinical

Description


Duties and Responsibilities:
1. Product Registration:

Submitting Registration files and maintenance of registered files for assigned products
Poviding regulatory related information to principals/regional as per request
2. Pharmacovigilance:

Provide back up support and ensure that Adverse Drug Reaction (ADR) reports are properly filed as per principle requirements and local Malaysian Adverse Drug Reaction Committee (MADRAC) and Medical Device Authority requirements are met
Provide back-up support and ensure that Periodic Safety Update Reports (PSUR

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