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Seoul, Seoul, Korea, Republic Of
Job reference: R-038417
Posted date: Dec. 19, 2018

Purpose of the job

1 year Contract. This position is responsible for getting IND and relevant variation approval in Korea within a planned time-line and taking the most appropriate actions to keep the company business.

Typical Accountabilities

  1. Product registration & maintenance

  • Prepare for IND or IND variation according to the local and global strategy in collaboration with SM&M team.
  • Implement/manage products registration procedures required by Korean pharmaceutical regulation to achieve the earliest market entry.
  • Harmonize Korean products labels and promptly notice to GRA about local impositions for the labelling from the MFDS to avoid any local issue. Update the safety information in line with the CDS and other reference countries’.
  • Product lifecycle maintenance: Keep product license to be compliant with regulations.

  2. Product QA

  • Package compliance : Secure the package compliance in line with the local regulation and AZ compliance.
  • Responsible for company’s compliance into all relevant Korean and AZ’s procedure including Good Regulatory Practice (GRP).
  • Review the compliance of promotional literatures from regulatory perspective

  3. Relationship with customers(internal & external)

  • Maintain high level of authorities’ satisfaction through application of high professional standard in all contacts, quick resolution of authorities’ enquiries and provision of support.
  • Maintain positive relationship with local contractors, customers and internal staff.
  • Comply with the relevant regulations and AZK’s ethical business practices with full understanding of the code of conducts.

  4. Intelligence Gathering

  • Get any information relating to changes in the relevant regulatory regulations and health authorities and report to RA manager on any expected impact on our business.

Functional Capabilities

  • Understanding of local regulation and reflect into strategy
  • Secure the compliance required by local regulation as well as global
  • Relationship and communication skill with Health Authority and Global

Essential Qualification

  • 1~2 years of experience in the regulatory area.
  • Negotiating, communication and interpersonal skills
  • Good command of spoken and written English

Desired skills or requirements

  • Experience of working on cross-functional teams
  • Knowledge of the drug development process
  • Pharmacist license

RA IND Specialist(1 year contract)

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