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Date:  Dec 11, 2024
Location: 

Hung Hom, HK

Job Type:  Long-term/regular

 Regulatory Affairs Specialist M/F (29561)

 

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 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

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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