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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Regulatory Affairs Specialist

Job Duties

 

  • Help to deliver and explain China Regulations requirement to HQ.
  • Provide preliminary assessment for developing registration strategy.
  • Coordinate product preparation for registration lab test; deliver China request to R&D for gap analysis.
  • Compile, submit and follow up on product lab test, new registration, variations , renewal and manufacturer GMP/QS inspection (if requested by NMPA) to achieve approval.
  • Review product labeling and packaging materials in compliance with local regulation and follow up implementation of approval information, i.e. change of China label and package insert.
  • Monitor routinely drug regulation and policy changes; inform Guerbet with proactive plan (if could be managed by RA only) or spread out to the responsible department (if cross-function coordination needed).
  • Archive submitted dossier and provide a copy to HQ, maintain local registration files and local RA database. 
  • Good/self-buildup relationship with NMPA, CDE, lab test institute. Efficient communications with China authorities with well tracking record.
  • Handle Import Drug License if require to help for customs clearance or declaration
  • Support in providing documents on drugs as required by cross functions, i.e. QA, AE, complaints, etc. upon approval of China RA manager or GM.
  • Support other tasks with RA expertise to external partner or Guerbet internal, i.e. product profile summary; commercial lab test; communication bridge between local team and HQ RA.
  • Help in reviewing commercial tools from RA point of view to have them aligned with local regulation, PI and SMPC
  • Support PV when assessing, renewing CCSI
  • Intents to learn regulation affairs about medical device
  • Other tasks as required by the company

Required Skills & Background

 

  • 3+ years’ RA experience in drug, esp. on import drug registration. Past experience in manufacturing RA and/or CDMO activities is preferred.
  • Good to have sense on medical device registration
  • Bachelor or higher degree. Pharmaceutical or biochemistry related academic background preferred
  • Good communications and interpersonal skills
  • Good writing and oral English skill
  • Multitasking management, Sharing, Passion, Cooperative;
  • Detail-oriented and work according to procedures, rules and regulations.

Reasons to join us

 

Much more than a competitive salary, we offer continued personal development, we offer an interesting opportunity to join our International Team.

When you join Guerbet Group, you

  • Are choosing the world's leader in the technological sector of diagnostic and interventional imaging
  • Are joining our 2850 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life in more than 80 countries all over the world
  • Are joining a company where we value our diverse team coming from various horizon

 

We # Achieve # Cooperate # Care # Innovate at Guerbet.