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(Sr.) Associate Regulatory

Category:  Regulatory
Location: 

Taipei, Taiwan, TW

   

Key Responsibilities and Job Tasks

 

  • To devise and successfully implement regulatory affairs schedules that apply to the marketing strategy and helps achieve the corporate objectives.
  • To ensure speedy registration of NN products and indications.
  • To liaise with all concerns to ensure that all regulatory permissions and licences are duly obtained, updated and maintained.
  • To ensure that overall RA performance, meet the criteria/requirements as defined by line Manager, HQ RA and NN procedures
  • To well establish and maintain relevant regulatory system in NN in compliance with NN procedures and requirements
  • To ensure all NN products and labelling information conform to local regulations, directions and requirements
  • Responsible for periodic reporting PBRER to TFDA on time
  • To cooperate with marketing and supply chain and support on regulatory to ensure business running smoothly.
  • To be responsible for archiving of documents and act as a RA archive administrator
  • Ad-hoc tasks according to business needs

 

 

Minumum Qualifications

 

  • Master of Science (preferable) or Bachelor, Major in pharmacy or Medical related fields
  • More than 4 years for Regulatory Affairs in the pharmaceutical industry
  • TOEIC >=800
  • Advanced verbal and written skills in English
  • Good communication and negotiation skills
  • Ability to build good relationships with key stakeholders
  • Ability to deliver quality results under pressure
  • Good team player, good at collaborating with cross-function
  • Advanced skills using Microsoft Office 360, especially Microsoft Word, Microsoft PowerPoint, and Microsoft Excel

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.