RA (Senior) Specialist/Associate Manager

Job Description

Role description
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.

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

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 practice 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

• Sufficient regulatory knowledge and experience
• Good command of spoken and written English

Qualifications

• Education: BA or MA biology-related science (pharmacy preferred)
• Language: Korean and English
• Work Experience: Regulatory experience for 5 year minimum, Pharma industry experience 5-10 years
• Competencies:
• Experience of working on cross-functional teams
• Knowledge of the drug development process

※ 채용 절차법에 따른 고지 사항

1. 제출한 서류는 채용 절차법에 따라, 일체 반환 의무가 없습니다.

2. 보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.

3. 해외 여행 결격사유가 없어야 합니다.

4. 본 채용은 수시진행으로, 우수인력 채용 시 마감될 수 있습니다.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.