Regulatory Affairs Specialist

Regulatory Affairs Specialist M / F (29975)

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 and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

Regulatory Affairs, compliance and administrative duties

Countries in the scope of responsibilities : ASEAN countries

Regulatory Affairs

• Drive drug & medical device registrations and variations in accordance with relevant regulations and develop regulatory strategy to obtain the product approval within target timeframe.
• Maintain Guerbet products’ licenses in responsible countries
• Keep abreast of regulatory procedures and product changes to ensure registration dossiers are maintained in compliance with local and corporate instructions.
• Effectively communicate and collaborate with local RAs and HQ RA team in France and US in order to develop Regulatory Strategies
• Provide local regulation intelligence to internal stakeholders
• Maintain registration database locally
• Support other regulatory topics in collaboration with cross-functional team, e.g. commercial, marketing and supply chain etc.

Compliance and Administrative Duties

Educations & Experiences

Skills & Qualifications

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.