Share this Job

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

Responsibilities

Regulatory

  • Drug product registration/ product variation applications.
  • Follow up amendments related to MA license variation
  • Monitor routinely pharmaceutical regulation and policy changes and assess impact for timely implementation and notice of other stakeholders
  • Maintain / manage registration files and RA databases in shared drive of RA.
  • Proof reading product package label against approved label and the labeling regulatory requirement.
  • Communication with regulatory authorities and company headquarters.
  • Submission of drug reimbursement application to HIRA or MoWH.
  • Support drug reimbursement project.
  • Promotional material (e.g., product brochure) review against regulations and product approved label.
  • If required, answer/fulfill requests / queries originating from local authorities(MFDS, MOHW, KPIS, and HIRA etc.)

 

Pharmacovigilance

  • Handling of drug safety related information and report it to HQ and local authority –Serious adverse events from studies and spontaneous adverse events occurred from products
  • Report monthly reconciliation with MIS & Quality complaints
  • Provide PV training to relevant stakeholders
  • Fulfill the required tasks according to local & global procedure and regulations.
  • Management of local PV SOPs
  • Ensure a scientific and regulatory intelligence related to Pharmacovigilance.
  • Learn HQ PV system & procedures and assess/ implement it to local SOPs & procedures.
  •  Fulfill MFDS PV inspection
  • To be registered to MFDS as PV responsible pharmacist.

 

Educations & Experiences

  • Qualification of pharmacist in Bachelor or Higher degree.  

  • 3-5 years’ experience in RA and/or PV in pharmaceutical company

 

Skills & Qualifications

  • Proficient in MS Office, including Word, Excel and PowerPoint

  • Effective communication and interpersonal skills

  • Good verbal and writing English skill is preferred

  • Knowledge of pharmaceutical regulations