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Regulatory Affairs Supervisor

Category:  Regulatory
Location: 

Beijing, Beijing, CN

   

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join  Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.

 

The position

 

  • Regulatory Planning
  • Submissions and Approvals for license renewal, variation, deregistration, etc.
  • Regional Regulatory Affairs
  • Regulatory Compliance & System
  • Cross Functions/Departments Supporting
  • Regulatory Influence

 

 

Qualifications

 

  • Relevant graduate level degree, e.g. Pharmacy, Pharmacology, Biology.
  • Fluency in both written & spoken English.
  • Min 1+ years experience in RA area in pharmaceutical industry or related industry like medical devices or healthcare industry;
  • CMC relevant experience is preferred.
  • PHD in biologics is preferred.
  • Have or acquire in-depth knowledge of local regulations pertaining to product registration requirements for pharmaceutical products and devices, skill of project management
  • Have or acquire overall understanding of the local business decision-making process that impacts the regulatory strategy.
  • Skill of communication and argument with HA

 

About the department

 

In CMRQ (Clinical Medical Regulatory and Quality),We commit to bringing our products to Chinese market with the fastest speed and top quality, and applying the most scientific way to communicate our products' benefits to our customers. We have 6 team in CMRQ aiming to portfolio evaluation and overall strategy; New product approval, licence maintenance, Product localization; Clinical evidence trial operation Phase (I-IV, NIS); Multiple stakeholders’ engagement (HA/KOLs/investigators) and Medical evidence generation/communication.

 

Working at Novo Nordisk

 

At Novo Nordisk we recognise 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 the communities we operate in.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

 

Millions rely on us 

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. Together, we’re life changing.