Brand Regulatory Manager
- Beijing, China
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:
• Provide regulatory inputs in new project development strategy discussion; Lead or coordinate both local and global team on registration plan; Be accountable on the implementation the decided project registration strategy by projects planning and tracking
• Be accountable on achieving the target timeline of submission and approval; Be accountable on the communication with HAs to properly address the concerns on projects; and the coordination on related HA meetings; Be accountable on the communication with Global team on the related regulatory issues on the responsible projects.
• To solve the regulatory issues via communication and negotiation with HAs if necessary；Review/approve of promotional materials and press releases for NP4 Managerial (MCC review);Lead or chair the CPT meetings for responsible project and be accountable to provide regulatory support to other functional team;
• Contribute to optimize DRA internal operational procedures whenever is needed;Be accountable for ensuring regulatory compliance for the responsible brands like CMC, BPI，PSUR, RMP, registration master file and timely update in DRAGON;
• Ensure regulatory activities comply with Novartis internal Code of Conduct and SOPs/WIs during routine work;
• Monitor regulatory changes and report to department head timely; Support line manager to control project cost according to budget
• Coach the junior levels; Acting as deputy in the absence of the department head and lead team daily operation
What you'll bring to the role:
• At least 4 years in RA and/or drug/biologic development which include 2-3 years and above of
demonstrated accomplishment in RA filed;
• The experience in filing global trial CTA independently;
• The experience in filing and obtaining NDA approval;
• The experience in various types of regulatory submission/approvals;
• The experience in oncology product submission is a plus.
• Bachelor or above with Pharmaceutical/Medical background
• Fluency in English and Chinese (oral and written)
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
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