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Date:  Jan 9, 2025
Location: 

Seoul, KR

Job Type:  Long-term/regular

 Regulatory Affairs Specialist M/F (29764)

 

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

 

Regulatory

  • Drug product registration/ product variation applications.
  • Follow up amendments related to MA license variation
  • Monitor routinely pharmaceutical regulation and policy changes and assess impact for timely implementation and notice of other stakeholders
  • Maintain / manage registration files and RA databases in shared drive of RA.
  • Proof reading product package label against approved label and the labeling regulatory requirement.
  • Communication with regulatory authorities and company headquarters.
  • Submission of drug reimbursement application to HIRA or MOHW.
  • Support drug reimbursement project.
  • Support RA priority and plan establishment aligned with local and corporate objectives
  • Collaborate with cross-functional team on product launch and change control management initiated by product registration update
  • If required, answer/fulfill requests / queries originating from local authorities (MFDS, MOHW, KPIS, and HIRA etc.)

 

Quality Assurance

  • Qualified person for Drug
  • Approve annual internal audit and make sure that the CAPA is properly implemented.
  • Approval of annual quality review report for all MA approved drug
  • Make sure all imported batches quality control required by local laws & regulations.
  • Ensure the local redressing is done in compliance with the relevant local laws & regulations and internal SOPs
  •  Make sure that all the goods are distributed with appropriate local redressing materials that comply with relevant local laws/regulations
  • Batch release approval (Drug)
  • Manage Korean package artworks and Korean drug barcode in compliant with local/global procedure and KR regulation

 

Compliance

  • Conducting promotional material (e.g., product brochure) review against regulations and product approved label

 

Education

  • Relevant qualification of registered pharmacist
  • 7 ~ 10 years’ experience in RA and/or QA in pharmaceutical company
  • Knowledge of pharmaceutical regulations
  • Proficient in MS Office, including Word, Excel and PowerPoint
  • Good verbal and writing English skill is preferred
  • Efficient communication and interpersonal skill

 

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.

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