注册高级经理

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Date: Apr 21, 2024

Location: Beijing, Beijing, CN, 100016

Company: Merck KGaA Darmstadt, Germany

 

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:

  • Assist line Manager in implementation of registration plan for new product in China.
  • Assist in preparation of applications for new products within relevant therapeutic areas, variations of marketed products and license renewals within the set time frame. 
  • Provide regulatory support to company business.

 

Functional Tasks

  • to be responsible for regulatory strategies development for responsible products
  • give regulatory comments for all activities of related products
  • communicate with global RA, CMC and manufacturing colleagues to explain Chinese regulation, requirement and RA plans
  • communicate with authorities to achieve registration objectives
  • evaluate dossiers provided by global related functions and prepare regulatory dossiers for submission
  • work together with logistic colleagues to prepare products registration plan to make sure there is no out of stock situation happened.
  • participate RA related organization to share RA voice in these organizations.
  • support associate regulatory affair director in some RA related activities in the company

 

Local Responsibilities

  • to be responsible for regulatory strategies development for responsible products
  • give regulatory comments for all activities of related products
  • communicate with local stakeholders to explain Chinese regulation, requirement and RA plans
  • evaluate dossiers provided by global related functions and prepare regulatory dossiers for submission
  • work together with logistic colleagues to prepare products registration plan to make sure there is no out of stock situation happened.
  • participate RA related organization to share RA voice in these organizations.
  • support associate regulatory affair director in some RA related activities in the company


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!

 


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