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Regulatory Affairs Specialist

GuerbetHung Hom, HK

30+ days ago

Job description

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

Ensure company’s products comply with the regulations

Plan and coordinate packaging changes with related departments

Ensure validation of promotional materials in compliance with local regulations and corporate policy.

Maintain accurate information in product labeling by collaborating with distributors and ensure compliance with local labelling requirements

Educations & Experiences

Bachelor’s degree in health-related science, life science; Pharmacist or related academic background is preferred

3- 4 years of relevant experience in pharmaceutical registration and experience in medical device registration in ASEAN countries and / or Hong Kong is preferred

Candidate with more experience will be considered as Senior Regulatory Affairs Specialist, whilst less experience will be considered as Regulatory Affairs Specialist

Skills & Qualifications

Excellent verbal and written communication skills in English and Cantonese

Proficient in MS Office, including Word, Excel and PowerPoint

Previous experience in a multinational environment

Effective communication and interpersonal skills

Detail-oriented and cross-functional team player

Work precisely according to procedures, rules and regulations

Recognize recurring issues and analyse their causes in order to reach a solution

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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Specialist • Hung Hom, HK