388801BR
Apr 02, 2024
China
About the Role
Internal Role Title: Brand Regulatory Manager
Location: Beijing, Hybrid
About the role:
In this role, you will be accountable for regulatory strategy development and the implementation of the registration strategy in China.
Key Responsibilities：
• 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; Be accountable for ensuring regulatory compliance for the responsible brands like CMC, BPI，PSUR, RMP, registration master file and timely update in DRAGON;
• 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
• 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.
Location: Beijing, Hybrid
About the role:
In this role, you will be accountable for regulatory strategy development and the implementation of the registration strategy in China.
Key Responsibilities：
• 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; Be accountable for ensuring regulatory compliance for the responsible brands like CMC, BPI，PSUR, RMP, registration master file and timely update in DRAGON;
• 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
• 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.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Role Requirements
Essential Requirements:
• 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;
Desirable Requirements:
• Bachelor or above with Pharmaceutical/Medical background;
• Fluency in English and Chinese (oral and written).
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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
• 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;
Desirable Requirements:
• Bachelor or above with Pharmaceutical/Medical background;
• Fluency in English and Chinese (oral and written).
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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
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? https://www.novartis.com/about/strategy/people-and-culture
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: https://talentnetwork.novartis.com/network
Development
REG AFFAIRS GDD
China
Beijing
CNIBR Co. Ltd.
Research & Development
Full Time
Regular
No
