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
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