Date:  Feb 3, 2024
Location: 

Tokyo, JP

Job Type:  Long-term/regular

 Regulatory Affairs Manager, Head Pharmacist (Soukatsu) M/F (28487)

 

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

 

Job Description 
1.    General Marketing  Compliance Officer (SOKATSU-SEKININSHA)

Responsible to assure compliance with GVP and GQP through supervision and instruction to safety manager and quality assurance manager.  Must report issues and risks to the MAH.  Name and address are registered with government agencies as contact point for GVP/GQP related matters.

2.    Regulatory Affairs Regulatory Affair (RA)

  • Is the contact person dealing with the authorities for RA in Japan.
  • Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by the Corporate RA department. Submits variations, renewals or new marketing authorization applications to competent authority. Attaches any relevant documentation according to the local requirements. 
  • Is in charge of the follow-up of the pending approvals. Answers questions and provides additional documentation when requested by the authority. Informs the Corporate RA department about the approval status of the dossiers. 
  • Is in charge of the local regulatory intelligence. Informs the Corporate RA department about new regulations in Japan.
  • Proposes regulatory strategies based on expertise and knowledge of the Japanese laws about medicines.
  • Revises and validates the texts of the packaging materials and SmPCs of the products.

 

Education, Background 

  • Pharmacist license in Japan. (mandatory as stiplulated by law)
  • Extensive knowledge of GVP and GQP for prescription drugs
  • Fluent in Japanese. 
  • Business Level English (TOEIC>800).

 

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 committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants.

 

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.

 

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