다국적 의약품 수입 판매사 - RA.PV업무 (주임-대리급)
본문
Business unit: RA/PV
In this role, you will be responsible for obtaining and maintaining market authorizations, ensuring full compliance with local regulatory requirements, and supporting overall commercial strategies.
Also, you will be responsible for pharmacovigilance (PV) activities, post-marketing surveillance (PMS) management, and overall regulatory compliance.
Key Responsibilities
Regulatory Submissions & Strategy
Lead the preparation, review, and submission of high-quality dossiers for New Drug Applications (NDAs), line extensions, variations, and license renewals in alignment with business objectives and MFDS regulations.
Health Authority Engagement
Act as the primary local point of contact for the MFDS and relevant regulatory bodies. Independently manage daily communications, queries, and negotiations to secure timely approvals.
Cross-Functional Collaboration
Partner effectively with Commercial, Marketing, Supply Chain, and Quality teams to facilitate product launches, review materials, and support projects
Product Review and Regulatory Assessment
Conduct regulatory assessments and provide strategic advice on product classification, claims substantiation, labeling, registrations, notifications, and other market requirements.
Regulatory Intelligence & Trend Monitoring
Lead Regulatory Intelligence (RI) activities by continuously monitoring evolving regulatory landscapes and translating emerging trends into strategic guidance
Product lifecycle maintenance
Keep product license to be compliant with regulations.
Product renewal
Ensure timely submission and renewal of product license in compliance with regulations.
PV Quality & Compliance Oversight
Prepare, support, and lead PV internal/external audits and regulatory inspections
Compliance activities management for pharmacovigilance
Conduct the local product compliance related activities in collaboration with stakeholders as needed.
Aggregating reporting
Review and translate the global aggregate safety reports (e.g., PSUR, PBRER, DSUR) and submit local aggregate safety reports in compliance with MFDS regulations and timelines
SDEA/PVA management
Draft, review, and negotiate local PVAs/SDEAs, while ensuring all third-party vendor contracts include appropriate safety terms and undergo periodic compliance review
PMS(Post-marketing surveillance) management
Skills
Sufficient regulatory knowledge and experience
Good written and verbal communication skills in English
Ability to develop and manage timelines, including its updates
Ability to maintain relationships with coworkers, service providers, and suppliers
Extensive experience and strong competence in direct communication and negotiation with the MFDS
Qualifications
Bachelor’s in pharmacy or equivalent in a health-related field
+3 years of work experience in the regulatory submission/approvals
Experience in pharmacovigilance or related areas
Work experience in new product registration and MA transfer
Good knowledge of GCP/GVP
* 워드화일: 1차 면접시-- 국문 이력서,경력기술서,자기소개서 --> 2차면접시 영문이력서,경력기술서,자기소개서 제출 예정
In this role, you will be responsible for obtaining and maintaining market authorizations, ensuring full compliance with local regulatory requirements, and supporting overall commercial strategies.
Also, you will be responsible for pharmacovigilance (PV) activities, post-marketing surveillance (PMS) management, and overall regulatory compliance.
Key Responsibilities
Regulatory Submissions & Strategy
Lead the preparation, review, and submission of high-quality dossiers for New Drug Applications (NDAs), line extensions, variations, and license renewals in alignment with business objectives and MFDS regulations.
Health Authority Engagement
Act as the primary local point of contact for the MFDS and relevant regulatory bodies. Independently manage daily communications, queries, and negotiations to secure timely approvals.
Cross-Functional Collaboration
Partner effectively with Commercial, Marketing, Supply Chain, and Quality teams to facilitate product launches, review materials, and support projects
Product Review and Regulatory Assessment
Conduct regulatory assessments and provide strategic advice on product classification, claims substantiation, labeling, registrations, notifications, and other market requirements.
Regulatory Intelligence & Trend Monitoring
Lead Regulatory Intelligence (RI) activities by continuously monitoring evolving regulatory landscapes and translating emerging trends into strategic guidance
Product lifecycle maintenance
Keep product license to be compliant with regulations.
Product renewal
Ensure timely submission and renewal of product license in compliance with regulations.
PV Quality & Compliance Oversight
Prepare, support, and lead PV internal/external audits and regulatory inspections
Compliance activities management for pharmacovigilance
Conduct the local product compliance related activities in collaboration with stakeholders as needed.
Aggregating reporting
Review and translate the global aggregate safety reports (e.g., PSUR, PBRER, DSUR) and submit local aggregate safety reports in compliance with MFDS regulations and timelines
SDEA/PVA management
Draft, review, and negotiate local PVAs/SDEAs, while ensuring all third-party vendor contracts include appropriate safety terms and undergo periodic compliance review
PMS(Post-marketing surveillance) management
Skills
Sufficient regulatory knowledge and experience
Good written and verbal communication skills in English
Ability to develop and manage timelines, including its updates
Ability to maintain relationships with coworkers, service providers, and suppliers
Extensive experience and strong competence in direct communication and negotiation with the MFDS
Qualifications
Bachelor’s in pharmacy or equivalent in a health-related field
+3 years of work experience in the regulatory submission/approvals
Experience in pharmacovigilance or related areas
Work experience in new product registration and MA transfer
Good knowledge of GCP/GVP
* 워드화일: 1차 면접시-- 국문 이력서,경력기술서,자기소개서 --> 2차면접시 영문이력서,경력기술서,자기소개서 제출 예정
