-Provides strategic direction to teams to achieve registration and drives preparation and submission of regulatory documentation. Interacts and negotiates with regulatory agencies in order to expedite competitive approval of pending registration applications and serves as a regulatory liaison on the project team(s) throughout the product lifecycle. Ensures timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Coordinates and reviews preparation of regulatory submissions, including preparation of specific regulatory components.

Major accountabilities:

•Is Leader of global regulatory team for the assigned program.

•Is responsible for Heavyweight project in development or a brand with major ongoing development activities, requiring complex regulatory strategies.

•Functions as a core member of the GPT (Global Program Team) to define the global regulatory strategy for the development, submission, approval and life cycle management of the project(s) and/or brand(s) in the major and emerging markets.

•Provide global regulatory direction and evaluate regulatory risks/gaps and trade -offs for the overall development plan

develop contingency plans for identified risks -Ensure that execution of regional regulatory strategies are aligned with global strategy -Responsible for obtaining timely consultation with Novartis regulatory advisory boards on regulatory strategy -Lead interactions with regulatory consultants for strategic input and challenge -Accountable for developing and driving the regulatory advocacy strategy -Develop global regulatory strategy and plans for Health Authority (HA) interactions -Responsible for implementation of CDS into labels in major regions (US, EU, Japan and Emerging Growth Markets) -Review of global promotional materials and press releases for NP4 Managerial -Leads DRA subteam consisting of RPRM’s across regions.

•Provides mentoring and coaching for members of DRA subteam.

•Contributes to and often leads the development of departmental and functional/business unit goals and objectives.

•Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable) Key performance indicators:

•Timely preparation of high quality regulatory documents -Health Authority issues and major issues with cross functional impact are appropriately highlighted -Project and stakeholder feedback -Adherence to Novartis policy and guidelines Minimum Requirements:

Work Experience:

•Functional Breadth.

•Strategy Development.

•Critical Negotiations.

•Cross Cultural Experience.

•Representing the organization.

•Operations Management and Execution.

•Project Management. Skills:

•Clinical Trials.

•Cross-Functional Teams.

•Drug Development.

•Lifesciences.

•Negotiation Skills.

•People Management.

•Problem Solving Skills.

•Regulatory Compliance.

•Risk Management.

•Strategy Execution. Languages :

•English.

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

加入我们的诺华网络：这不是您心仪的职位？欢迎加入诺华人才社区，与我们保持联系，及时了解合适的职业机会。您也可以关注诺华集团招聘微信公众号及诺华集团招聘微信视频号。

薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。

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?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

Benefits and Rewards: Go to Novartis career website to learn about all the ways we’ll help you thrive personally and professionally.

Problem Solving Skills

Negotiation Skills

Regulatory Compliance

Risk Management

Cross-Functional Teams

Drug Development

People Management

Clinical Trials

Strategy Execution

Lifesciences