[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 GRPKnowledge of the drug development processAbility to form partnerships, build and maintain relationshipsExperience of working on cross-functional teamsExcellent ability to work according to global standardsAbility to work independentlyExcellent time management/Planning/Organizational skillsGood attention to detail

[Qualifications]

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

※ 채용 절차법에 따른 고지 사항

1. 전자우편으로 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

08-5월-2025

Closing Date

07-5월-2025

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.