注册事务副总监

Posted 08 Feb 2024

Beijing, Beijing - China

Req Id 271758

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


Your role: 

  • Develop, support and implement registration strategy and plan for new product in China.
  • Responsible for the applications and approvals for New Products within relevant therapeutic areas, variations of marketed products and license renewals within the set time frame.
  • Provide regulatory expertise to support company business.
  • Conduct in compliance with local regulatory agency requirements as well as relevant company policy and internal SOP.
  • Responsible for coaching and developing subordinates.

Global Responsibilities

  • Develop, support and implement registration strategy and plan for new product in China within relevant therapeutic areas.
  • Manage registration submissions for new products, clinical trial applications.
  • Ensure successful implementation of registration strategy and high quality of filing dossier.
  • Set up necessary process & infrastructure and monitor the overall review process and response to the additional data request or queries from regulatory authorities to ensure the set registration strategy and timeline being implemented in a timely manner.
  • Set up and maintain direct contact with relevant Global Regulatory Therapeutic Area.
  • Undertake interactions and negotiations with Regulatory Authorities to secure and optimal regulatory approvals concordant with strategic company goals.
  • Negotiate with regulatory authority on product labeling to ensure optimal Chinese labeling.
  • Support GRA to be updated on the upcoming significant changes of regulations or new regulations issued by the regulatory authorities or other governments, analyze/predict its impact on company business and corresponding actions GRA needs to take, as well as provide the comments/suggestions to the government in timely manner.


Local Responsibilities

Interfaces with other Department/Functions :

  • Other Functions of Beijing Hub
  • Other Functions of Global R&D
  • Other Functions of CMG

 

External Interfaces :

Local Regulatory Affairs of CMG in Asian countries

  • Regulatory Authorities
  • Other Pharmaceutical Companies
  • Trade/Industry Associations
  • Academies

 

Who you are:

  • Independent manage product RA activities including marketed products and development product.
  • Have ~10 yrs RA experience.
  • Good English skill and can independent communicate with global stakeholders.
  • Good communication skill and collorbration 


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

Apply Now