China Job Openings
Novartis
Regulatory Affairs Manager
FULL TIME
September 2, 2024
Summary
指导提交产品注册、进度报告、补充、修订和/或定期经验报告的进度。 为团队进行交互沟通提供战略性产品指导，并与监管机构协商证据。 与监管机构人员进行沟通和协商，以加快批准未决注册并回答任何问题。 在整个产品生命周期中担任项目团队的监管联络员。 确保快速及时批准新药、生物制品/生物技术和/或医疗器械，并确保上市药品或医疗器械的持续批准状态。 担任市场营销或研究项目团队和政府监管机构的监管代表。 向开发和/或营销团队提供有关制造变更、生产线扩展、技术标签、适当法规和解释的建议。 协调、审查，或编制要提交的报告。
About the Role
Key Responsibilities：
Commitment to Diversity and Inclusion / EEO:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Essential Requirements:
Desirable Requirements:
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 diversityandincl.china@novartis.com 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 We Chat Official Account and Novartis Recruitment We Chat Video Account.
- 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
Commitment to Diversity and Inclusion / EEO:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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 diversityandincl.china@novartis.com 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 We Chat Official Account and Novartis Recruitment We Chat 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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Development
Business Unit
Innovative Medicines
Location
China
Site
Beijing (Beijing)
Company / Legal Entity
CN14 (FCRS = CN014) China Novartis Institutes for Bio Medical Research Co., Ltd.
Functional Area
Research & Development
Job Type
Full time
Employment Type
正式
Shift Work
No
无障碍及便利 设 施
诺华 承 诺 与残障人士共事并 为 他 们 提供合理的便利 设 施。如果您由于健康状况或残障 在招聘 过 程的任何 环 节 需要合理便利 设 施 或者 为 了履行 职 位的基本 职 能 请发 送 电 子 邮 件至 [email protected] 告知您的需求和 联 系方式，并在 邮 件中附上您的 职 位申 请编 号。New Job Alerts
Keller Executive Search
Freight Shipping Sales Manager (Shanghai)
September 23, 2024
View Job DescriptionKeller Executive Search
Cargo Shipping Sales Manager (Shanghai)
September 23, 2024
View Job DescriptionLooking for similar job?
HSBC
Senior Regulatory Compliance Manager, HSBC Broker
FULL TIME & CONTRACT
August 30, 2024
View Job DescriptionMaquet (Shanghai) Medical Equipment Co.,
Director Quality and Regulatory Compliance, Eastern Asia
August 29, 2024
View Job DescriptionSee What’s New: Novartis Job Opportunities
Novartis
MEDICAL SCIENTIFIC LIAISON MANAGER
Madrid
FULL TIME
September 20, 2024
View Job DescriptionNovartis
MEDICAL SCIENTIFIC LIAISON MANAGER
Madrid
FULL TIME
September 20, 2024
View Job DescriptionNovartis
Senior Global Risk Management Plan Manager
Barcelona
FULL TIME
September 20, 2024
View Job DescriptionNovartis
MEDICAL SCIENTIFIC LIAISON MANAGER
Madrid
FULL TIME
September 20, 2024
View Job DescriptionNovartis
MEDICAL SCIENTIFIC LIAISON MANAGER
Madrid
FULL TIME
September 20, 2024
View Job DescriptionNew Job Alerts
Keller Executive Search
Freight Shipping Sales Manager (Shanghai)
September 23, 2024
View Job DescriptionKeller Executive Search
Cargo Shipping Sales Manager (Shanghai)
September 23, 2024
View Job Description