注册事务高级经理

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：

• In this pivotal role, you will lead the development and execution of regulatory strategies for new product registrations in China, driving approvals that directly advance patient access to innovative therapies. You will own the end-to-end regulatory submission process, from clinical trial applications through to product approval, ensuring the highest quality of filing dossiers and full alignment with both local and global regulatory requirements.
• You will establish and maintain the processes and infrastructure needed to monitor regulatory review timelines, coordinate responses to authority queries, and ensure strategic objectives are delivered on schedule. Acting as the primary interface between the China regulatory team and Global Regulatory Therapeutic Area functions, you will negotiate directly with regulatory authorities on product labeling to secure optimal outcomes for the Chinese market.
• Beyond new product registrations, you will manage license renewals and variations for marketed products, supporting the full product lifecycle in line with business objectives. You will contribute to the continuous improvement of regulatory systems, standard operating procedures, and working practices, and ensure all activities are conducted in compliance with applicable policies and standards.

Who You Are：

• You hold a degree in a Life Science or related discipline, with a higher qualification such as a Master's degree or PhD.
• You bring a minimum of 10 years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
• You have an excellent understanding of Chinese regulatory regulations, guidelines, and submission requirements.
• You have a proven track record of preparing and managing regulatory submissions and successfully achieving product approvals.
• You have demonstrated experience engaging and negotiating with regulatory authorities, including the National Medical Products Administration (NMPA).
• You communicate fluently in English, both written and spoken, and are able to collaborate effectively with global and local stakeholders

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety 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 a team that is dedicated to Sparking Discovery and Elevating Humanity!