348197BR
Jul 06, 2022
China

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• 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)

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Strategy Development Operations Management and execution Project Management
• Representing the organization functional breadth cross cultural experience
• High command of English language essential.

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
REG AFFAIRS GDD
China
Beijing
Research & Development
Full Time
Regular
No
careers default image
348197BR

Senior Franchise Head

Apply to Job Access Job Account