Summary
About the Role
Major accountabilities:
- Strategic Planning and Regulatory Policy Advisory: Assist the RI Head in developing strategic policy plans and creating innovative regulatory solutions to support RA project teams. Serve as key partner across therapeutic areas on policy issues, providing strategic advice to RA functions on NMPA regulatory environment for drug development projects and marketed products. Analyze impact of important emerging regulatory policies and new requirements on Novartis projects and business. Provides strategic analysis of China regulatory benchmarking data to cross-functional teams when necessary.
- Regulatory Environment Monitoring and Intelligence Support: Closely monitor and anaysis China regulatory environment, ensure timely delivery of intelligence information to RA team and other relevant functions. Fulfil regulatory intelligence requests in support of therapeutic area projects. Provide regulation support for cross-functional discussion and knowledge sharing. Maintain and develop China RA intelligence & policy materials and databases and promote the use of AI tool for RI daily work.
- Policy Shaping, Regulatory Feedback and External Engagement. Serve as regulatory policy support and/or lead of cross-functional teams responsible for proactively monitoring and responding to emerging scientific trends/strategies, both internally and externally, to shape and influence changes impacting Novartis and industry in the Chinese regulatory environment; support of commenting by Novartis subject matter experts on draft regulations, guidance; working to influence via interactions with NMPA, CDE and local trade organizations. Prepare and coordinate internal stakeholder feedback on proposed laws, regulations and guidance, to ensure consideration of Novartis positions by trade organizations. Collaborate with Novartis China cross-functional teams on emerging policies impacting China and the Novartis portfolio.
- Cross-functional Collaboration and Regulatory Implementation: Coordinate and lead internal cross-functional groups/task forces on implementation of regulatory guidelines in new and emerging areas.
- Training, Capability Building and Knowledge Sharing: Communicate new and emerging regulatory requirements by providing training sessions to China RA colleagues or cross-functional team. Organize team training on new regulatory environment changes, help deliver more learning resources both in Novartis and external.
Essential Requirements:
- Education: Science-based, health policy or legal studies BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) desirable.
- Languages: Fluency in English as a business language. Additional language is an asset
- Experience: Minimum 5 years of regulatory and drug/biologic development experience, Health Authority experience desirable.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
