343128BR
Apr 05, 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:
• A Project Manager who supports the Clinical Development Unit Head to establish the pro-gram
• Communicate and interpret China regulatory CMC requirements with global Reg CMC.
• Be responsible for local regulatory CMC dossiers preparation and compliant with local requirements.
• Retrospectively review CMC queries from CDE for all projects and analyze the trend of CMC requirements.
• Seek global support to provide relevant dossiers in new submissions.
• CMC support for local clinical trial activity, local registrations and product approvals, and regulatory compliance throughout the product lifecycle.
• Consolidate, contribute and coordinate Novartis comments on HA regulations and guidelines relevant to CMC.
• Establish and maintain sound working relationships with partners and customers and align objectives and priorities as appropriate to achieve optimal support.
• Coordinate CMC related trainings to RA team.

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:
• Master Degree or above with CMC related major;
• Fluent in Mandarin Chinese Good in English writing, reading, speaking and listening skills
• CMC background;
• Well understanding about R&D process and details;
• Good communication skills in matrix, work independently and good presentation skill;
• Team work spirit.

Desirable Requirements:
• More than 5 years regulatory related experiences multinational companies, and additional R & D working experience is preferred.

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
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343128BR

Regulatory CMC Manager

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