358214BR
Nov 17, 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:
• Global/ large regional regulatory affairs leader charged with the development (in collaboration portfolio heads) and implementation of regulatory strategy across the development portfolio, marketed products and/or line extensions through development, registration & approval including post approval commitments and life cycle management -typically within the assigned franchise and/or therapeutic areas or assigned region(s)/country(s)
• Ensures high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans
• Ensures high quality and professional interactions with HAs globally including participation in key formal and informal HA contacts as required
• Ensures compliance with global regulatory requirements and adherence to internal policies and processes and coordinate compliance activities at a global level
• Leads and supervises assigned regulatory liaisons including performance management, in collaboration with the global line functions
• Ensures synergy where appropriate across the group of projects at a global level
• 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
• People Leadership
• Representing the organization
• Collaborating across boundaries
• People Challenges
• Critical Negotiations

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
Shanghai
Research & Development
Full Time
Regular
No
careers default image
358214BR

Regulatory Affairs Head-Greater China

Apply to Job Access Job Account