[한국아스트라제네카] RA Specialist 채용

RA Specialist_Contract

 

 

 

 

 

 

 

 

 

Location:

Seoul, Seoul, South Korea

 

Job reference: R-015720

Posted date: Oct. 18, 2017

 

 

1. Purpose

 RA specialist is responsible for getting product approval in Korea within a planned time-line and taking the most appropriate actions to keep the company business and products license compliant with government regulations and company procedures including Good Regulatory Practice (GRP).

2. Typical Accountabilities

Product registration & maintenance

• Develop the regulatory strategy/plan for the earliest launch of new products on best conditions (indication, forms, minimum documents requirements etc) in Korea by sourcing necessary documents from HQ’s worldwide regulatory function.
• 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 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).

Relationship with customer (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.

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.
• Develop/maintain good relationship with government agencies and regulatory bodies to achieve above.

3. 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

 

4. Essential Qualification

- More than 3 years of experience in the regulatory department

- Negotiating, communication and interpersonal skills

- Good command of spoken and written English

 

5. Desired skills or requirements

- Experience of working on cross-functional teams

- Knowledge of the drug development process

 

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