Regulatory Operation Assistant

Job Description

Basic Functions & Responsibility (may not be limited to):

• Under supervision of Country Lead/Director/AssociateDirector/Manager/Sr.Specialist/Specialist, Regulatory Affairs the incumbent contributes in other regulatory tasks, as required.

• By discretion of Regulatory Affairs Management and due to organization and workload, all listed activities need not to be performed.

• Sr.Specialist or Specialist, Regulatory Affairs may act as supervisor regarding selected activities.

Major Activities for Regulatory Operation Assistant (may not be limited to):

Administrative office routines

• The incumbent is responsible for general administrative tasks, such as department administration.

• Ensures timely payment for registration filing, renewal and patent listing fee (Green list)

• Assists in compilation and submission of regulatory documents to the local regulatory authorities

• Assists in department administrative tasks, such as managing invoicing, meeting arrangements, coordinates agendas, takes and circulates minutes, makes travel arrangements, as applicable.

• The above-mentioned tasks are performed under supervision of RA managers.

Compliance

• Supports filing / archiving official documents in the department.

• Posts up-to-date LPC(Local Product Circular) on the company website

• Supports to maintain timely and accurate update of RA database 

• Ensures registration of KPIC (Korea pharmaceutical information center) product image and KPIS (Korea pharmaceutical information service) barcode

Labelling and artwork

• In connection with submission of MA (Marketing Authorization) applications and post-approval submissions assists in preparation, submission, translation and QRD (Quality Review of Documents) check.

• Supports artwork development process that artwork including all package components (leaflets, labels, outer cartons, etc.) is developed in a timely and correct manner according to relevant Artwork Management procedures.

• The above-mentioned tasks are performed under supervision of Country Lead/Director/AssociateDirector/Manager/Sr.Specialist/Specialist, Regulatory Affairs and in collaboration with relevant persons in medical and marketing departments as well as Regulatory Affairs International and Global Labelling

부서 행정/재무 업무 지원

제품/웹사이트 라이선스/허가증 관리, 경비 처리, 회의 준비 등

구매, 등록비/수수료 납부 등

부서 문서 보관관리 지원 등      

의약품 정보시스템 데이터 등록

약학정보원 제품 이미지, KPIS 바코드 등록

아트웍/허가 관련 업무 지원

아트웍 개발/검토, e-label 관리

컴플라이언스 업무 지원

데이터베이스 및 컴플라이언스 관리

해외 제조소 등록 업무 지원

신규 등록 및 연차보고 준비

- 신입 가능

- 4년제 대학 졸업자 (전공 무관)

- 영어 가능자 (이메일링, 문서 읽기/쓰기 가능 및 중급 수준 회화 가능)

- MS office 사용 가능

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

이 포지션은 1년 계약직입니다. (최대 2년까지 근무 가능)

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:

Temporary (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Accountability, Accountability, Adverse Event Report, Art Handling, Audits Compliance, Clinical Medicine, Communication, Data Quality Assurance, Documentation Compliance, Document Control Systems, Electronic Common Technical Document (eCTD), Employee Training Programs, Legal Archiving, Maintenance Processes, Management Process, Medical Review, Organization Administration, Pharmaceutical Regulatory Affairs, Policy Implementation, Product Approvals, Records Retention Management, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Applications, Regulatory Communications {+ 3 more}

 Preferred Skills:

Job Posting End Date:

09/30/2025

*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.

Requisition ID:R365890

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