Regulatory Affairs Manager M/F (30861)

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.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

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

• 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

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging, 
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet. 

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717