Regulatory Affairs Specialist

Job Description

Animal health New product registration (Biologicals and pharmaceuticals) and carry out variation to health Authority(APQA) and management of local QC matter with Pharmacist.

Need to check DPOC role and prepare Pharmacy inspection and self-inspection every year.

• Responsible for registration of new products and variation.

- Compile and submit registration document according to Animal Health registration procedure and Korean regulation

- Compile and submit the variation documents to authority according to request of HQ and Korean regulation

 

• Responsible for National/General QC test process

- Co-work with pharmacist and logistic team to proceed QC w/o problem

- Provide the test material and product sample related QC to APQA timely.

- If require, arrange the test materials for QC.

 

• Responsible for Pharmacovigilance and complaint report as DPOC

- Report and communicate with Global PV team in time

- Training regulation all employee for pharmacovigilance and complaint

report procedure

-Work out the PV Works system according to procedure

Required Skills:

Animal Health Care, Pharmacovigilance, Product Registrations

Preferred Skills:

Communication

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

 필수 조건 : 수의사

석사 학위 선호 / 업계 5년 이상 경력 선호

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/31/2026

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