注册事务药学经理

Posté 14 oct. 2022

Beijing, Beijing - China

Demander un identifiant 257213

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

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: 

Take Regulatory CMC role for chemical products for marketed products in China. Work together with local CMC regulatory activities with internal and external stakeholders, prepare CMC dossiers for regulatory submission in China; working together with global CMC team for final dossiers review and approval.

  • Working together with internal and external stakeholders to prepare CMC dossiers according to China registration regulation and guideline;
  • Coordinate with global CMC experts to review and approve CMC dossiers for regulatory submission.
  • Assess and communicate CMC regulatory requirements with internal partners to ensure all CMC submissions in compliance with applicable regulations and guidelines;
  • Update the organization on the evolving CMC regulatory requirements to ensure all relevant divisions/functions understand the impact and implications and take appropriate actions;
  • Engage and interact with regulatory agencies to reach aligned pathways/solutions for all CMC and QC related issues;
  • Drive decision making through communication and alignment across multiple functions/divisions;
  • Coordinate the preparation of CMC responses to regulatory agencies;

 

Who you are: 

  • Bachelor Degree or above in chemistry, or related pharmaceutical science;
  • Experience in CMC areas such as formulation and analytical. At least 3 years of regulatory CMC experience.
  • Knowledge in CMC regulatory requirement and ICH guidelines.
  • Excellent organizational, interpersonal and communication skills (oral and written);
  • Proven ability in cross-functional communication and alignment and ownership in resolving issues;

 

HR: 95518

Functional Area: Regulatory Affairs 


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. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

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