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Regulatory Affairs Officer (6 Months)

Company

Hyphens Pharma International Ltd.
Address Jakarta Raya, Indonesia
Employment type FULL_TIME
Salary
Category Manufaktur Farmasi
Expires 2023-09-30
Posted at 8 months ago
Job Description

Job Responsibilities

Quality Management

  • To provide support during GDP audit by BPOM.
  • To help maintain, update and/or create SOPs related to the cosmetic distributor license, PBF and medical device distributor license.
  • To support the overall certification process for CDOB (GDP) and CDAKB (GDP for medical device).

Regulatory

  • To support local regulatory team with new product registrations, variations, renewals and other regulatory concerns.
  • To provide assistance in MA transfer applications.


Job Requirements

  • Licensed pharmacist with working experience in regulatory affairs is preferred
  • Experience in handling SOPs and audit related to Medical device distributor licence and CDAKB (GDP for medical device) preferred
  • Possess good interpersonal and communication skills, positive attitude and result oriented
  • Meticulous and well-organized with an eye for details