Regulatory Affairs Specialist (1년 계약직)

[Role description]

RA Specialist is responsible for getting product approval in Korea within a planned timeline 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).

[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 lifecycle maintenance: Keep product license to be compliant with regulations.
• Prepare for IND or IND variation according to the local and global strategy in collaboration with SM&M team. (applicable to the person in charge)

Product QA

• Package compliance: Secure the package compliance in line with the local regulation and AZ compliance.
• Quality Control: Give advice to the QC lab based on regulatory knowledge and support the technical transfer.
• 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

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.

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.

[Skills]

Suggested skills based on Job Details

• Knowledge of the pharmaceutical industry and GRP
• Knowledge of the drug development process
• Ability to form partnerships, build and maintain relationships
• Experience of working on cross-functional teams
• Excellent ability to work according to global standards
• Ability to work independently
• Excellent time management/Planning/Organizational skills
• Good attention to detail

[Qualifications]

• Education: A degree in Pharmacy is preferred.
• Language: Good Command of spoken & written English
• Certifications: Pharmacist preferred
• Work Experience: More than 3-5 years of regulatory relevant experience

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