Head of Regulatory Management China

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.

Your Role:

This position will manage regulatory management for Life Science (LS) business China with effective management and strategy development. Drive, manage and coordinate regulatory management projects, including managing thought leadership initiatives, product registrations, license/permit application, authorities communication, supporting business needs, customer training / requests. Lead Regulatory Management China team. Facilitate and maintain excellent working relationship with government officials and customers.

Strategy:

• Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry / trade associations in terms of Life Science interests. Safeguard company strategic interests and objectives in arising regulations.
• Monitor and report on changes of relevant regulatory and compliance environment with impact with the Life Science business. Analyze available regulatory and compliance information.
• Effective coordination of strategic activities with the subject matter experts, local regulatory bodies and industry associations. Secure flow of information from/to authorities, industry associations and the Life Science organization.
• Manage and support businesses on evolving requirements in a rapidly changing legal landscape.
• Drive implementation of policies and instructions through monitoring, self-assessments and periodic audits in LS organization.
• Provide guidance and coordinate regulatory activities, such as certification / notification and it’s follow-up action together with internal / external stakeholders.
• Effective coordination of strategic activities with the company subject matter experts, local regulatory bodies and industry associations. Secure flow of information from/to authorities, industry associations and the Life Science organization.
• Training and support to internal stakeholders, external customers and relevant regulatory bodies. Provide relevant training to educate local marketing/sales colleagues about new regulatory trends and developments that drive our value proposition. Definition of processes to implement upcoming regulatory needs and requirements.
• Closely work with global/regional regulatory surveillance & advocacy team and regulatory subject matter experts to link the local advocacy activities with global/regional advocacy activities.
• Drive, manage and coordinate registration / notification / listing activities. Ensure the correctness and timeliness of these activities, interim follow-up change management and final outcome. Ensure tracking, maintenance and reporting of registration / notification / listing status.
• Ensure the relevant changes to product regulatory status are properly notified to the relevant authorities in a timely manner.
• Local regulatory compliance as it relates to new operation setup, business opportunities and product launches.
• Drive and develop digitalization strategy and automation tools to improve efficiency and improve data quality.
• Proactively contribute to APAC regulatory working group. Keep close interaction & collaboration with APAC and Global Regulatory SMEs.
• Define and clarify the roles & responsibilities of Regulatory Management and other internal functions for smooth collaboration.

Operation Excellence:

• Perform periodical internal audit, identify compliance process gaps, understand criticality of gap and build a roadmap for improving compliance controls, design of process change to implement business controls.
• Provide guidance in risk assessment, identify compliance impact to Life Science and provide recommendations to mitigate potential risk. Take active role to represent company in delicate or risk potential matters with authorities, inspectors and trade associations.
• Periodical compliance risk review and reporting to regional / global regulatory, and local business team.
• Ensure set up KPIs in alignment with business requirement, and the efficiency of KPIs tracking. 
• Implement global regulatory management policy and best practice procedures. Provide policy direction, advice and guidance to Commercial, Product Management, Quality, Manufacturing sites, Distribution, Trade Compliance, etc.

Process optimization: 

• Periodical review of Regulatory processes, ensure operational excellence in the areas of import & export and domestic compliance. Drive process optimization, set up good foundation to explore and enable digital solutions.
• Develop lean process with continuous improvement and measurement, to meet both compliance needs and operational efficiency improvement needs in close collaboration with multi-functions.
• Including Regulatory internal processes, and processes with other relevant functions (Quality, Distribution, Manufacturing Sites, Business, Trade Compliance, etc.).
• Identify opportunities for process efficiency and effectiveness in compliance through automation or process improvement, put in place compliance-related metrics and a program for continuous improvement.

Build for tomorrow:

• Initiate and manage Regulatory strategic projects in align with business strategy and organization development, eg. authority stakeholders mapping and communication strategy development, Regulatory capability development and training strategy, Regulatory assessment/ evaluation for business strategic investment projects, etc.
• Establish overview of all Regulatory relevant projects, define Regulatory roles (RACI) and actions. Periodical review and track project progress.
• Capability development: Develop comprehensive capability development strategy, covering talent attraction, on-board, development, retain, measurement and recognition. Develop Regulatory training program, training topics and position metrics, knowledge management. As an experienced Regulatory SME to provide training internally and externally.

Who You Are:

• Degree in pharmaceutical, life sciences, or related area.
• Fluent in Chinese native & English (verbal and written) is required.
• Experience of minimum 10 years in Pharma and Life Sciences industry, extensive knowledge in life science products.
• Broad and extensive knowledge of Biopharm, Pharm & Food materials, MD & IVD, regulatory and quality requirements. Extensive regulatory and quality knowledge of China laws and regulations of NMPA. Familiar with US and European regulations in above mentioned areas.
• Close working relationships with authorities (NMPA, provincial MPA, ChP Committee, NIFDC, NHC, CFDS, etc.)
• Customer centricity.
• Experience working in a global, matrix environment.
• People management experience to lead a team in complex and fasting changing environment. 
• Excellent interpersonal, presentation, listening and communication skills that will develop long term internal and external relationships at all levels.
• Strong organizational and time management skills.
• Ability to manage multiple priorities and deliver accurate outcomes.
• Ability to indirectly influence other organizations and cultures.
• Ability to train and educate others.
• Effective management by influence.
• Experience in thought leadership.
• Ability to work in multi-cultural teams.
• Proficient in MS Office Software (Word, Excel, PowerPoint, Project).
• Able to travel.

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!