Regulatory Affairs Specialist at Merck in Seoul, Seoul, South Korea

Regulatory Affairs Specialist Location: KOR - Seoul - Seoul (Seoul Square) 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 Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 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 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.