Regulatory Affairs Manager

서울 / 서울 강남 바이오,의약,제약 2026.07.15 ~ 채용시

Tasks

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

JOB TITLE: Regulatory Affairs Manager
HIERARCHICAL MANAGER: General Manager

ROLES AND RESPONSIBILITIES

Regulatory Affairs Leadership (Drug & Medical Device)

• Lead regulatory strategy and execution for pharmaceuticals and medical devices throughout the product lifecycle.

• Manage product registrations, maintenance activities, change controls, and interactions with health authorities.

• Provide regulatory guidance to cross-functional stakeholders and support business growth through proactive regulatory planning.

Market Access for Drug

• Develop and execute pricing and reimbursement strategies to maximize product value and patient access.

• Lead pricing submissions, reimbursement negotiations, and post-listing maintenance activities.

• Monitor healthcare policy developments and assess market access opportunities and risks.

Quality Assurance Oversight (Responsible pharmacist for Drug)

• Serve as the responsible pharmacist overseeing quality management systems and compliance with applicable regulations

• Ensure an effective Quality Management System (QMS) in compliance with local regulations and global GMP/GDP standards.

• Oversee product quality activities including batch release, complaints, recalls, change controls, and annual product quality reviews.

• Lead health authority inspections, audits, CAPA management, and quality compliance initiatives.

• Manage quality-related vendors, warehouse operations, and distribution compliance.

• Establish quality procedures, training programs, and continuous improvement activities to maintain inspection readiness

Pharmacovigilance (PV)

• Act as the Local Responsible Person of Pharmacovigilance (LRPPV) deputy for managing the PV system in Korea.

• Is responsible for ensuring that affiliate and local distributors(partners) comply with PV obligations, by implementing the vigilance agreements (SDEA) and their subsequent amendments and ensuring their compliance with the quality documents and the local regulations.

• Support to scientific and international regulatory intelligence. Provide expertise and support to analyze the impact of new scientific or regulatory information

• Support to maintain and update the quality documentation on his/her perimeter

• Check the compliance to quality referential on his/her perimeter

• Participate in the preparation and conduct of vigilance audits and inspections.

• Participate in the implementation and follow-up of corrective and preventive actions

• Review of training materials related to his/her field of activity

• Inform Regional Vigilance Manager or GVMI of any emerging issue, any incident or any information which may influence the security of the medicinal products or the medical devices or may need to be reported to health authorities

People Leadership

• Lead, coach, and develop RA, QA, and PV team members.

• Manage team performance, talent development, resource planning, and departmental budgets.

• Foster a collaborative and compliance-focused culture.

Requirements

• (MUST) Licensed Pharmacist in Korea
• 10+ years of experience in Regulatory Affairs, Quality Assurance, Pharmacovigilance, or related functions within the pharmaceutical industry.
• Strong knowledge of MFDS regulations and pharmaceutical compliance requirements.
• Experience leading cross-functional projects and regulatory authority interactions.
• Excellent stakeholder management and communication skills in Korean and English.
• Proven people management experience preferred

Information

커리어 수준

팀장.부장.10년이상

경력여부

경력

고용형태

정규직

급여사항

면접 후 협의

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전형방법

1차 Phone Screening
2차 GM 면접
3차 APAC 면접
4차 최종합격

제출서류

영문 이력서

접수방법

채용담당

블라인드 되었습니다.

Company

Guerbet Korea

외국계기업 제약바이오

서울 강남구 테헤란로38길 10

https://korea.guerbet.com/ko-kr https://www.guerbet.com

At Guerbet, we build lasting relationships so that we enable people to live better.

게르베코리아는 1998년에 설립된 게르베 그룹의 한국 법인입니다.
게르베코리아가 제공하는 대표적인 제품으로는 MRI 조영제인 도타렘®, X-ray 조영제인 제네틱스®, 텔레브릭스®, 그리고 Marcel Guerbet가 1901년에 개발한 세계 최초의 요오드 조영제인 리피오돌® 등이 있습니다.
게르베코리아는 세계 최고의 의약품 공급을 통해 여러분께 가장 신뢰받는 전문의약기업으로 확고히 자리매김하고자 합니다.
연구 개발에 대한 끊임없는 노력과 세계 최고의 의약품 생산에 대한 열정이 게르베의 사명임을 기억하고 국민의 건강과 한국 영상의학 분야의 발전에 기여할 수 있도록 항상 최선의 노력을 다하겠습니다.

Guerbet is a global leader in medical imaging, dedicated to improving patient care through innovation. With nearly a century of expertise, the company offers a comprehensive portfolio of pharmaceutical products, medical devices, and AI-driven solutions for diagnostic and interventional imaging. Guerbet invests 9% of its annual revenue in research and development, with dedicated innovation centers in France and the United States.