Regulatory Affairs Manager

REQ-10020963
Set 01, 2024
Cina

Sommario

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

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 [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

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

Development
Innovative Medicines
Cina
Beijing (Beijing)
Research & Development
Full time
正式
No

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REQ-10020963

Regulatory Affairs Manager

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List of links present in page
  1. https://www.novartis.com/about/strategy/people-and-culture
  2. https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
  3. mailto:[email protected]
  4. https://talentnetwork.novartis.com/network
  5. https://www.novartis.com/about/strategy/people-and-culture
  6. https://talentnetwork.novartis.com/network
  7. https://www.novartis.com/careers/benefits-rewards
  8. https://novartis.wd3.myworkdayjobs.com/zh-CN/Novartis_Careers/job/Beijing-Beijing/Regulatory-Affairs-Manager_REQ-10020963-1
  9. mailto:[email protected]
  10. https://novartis.wd3.myworkdayjobs.com/zh-CN/Novartis_Careers/job/Beijing-Beijing/Regulatory-Affairs-Manager_REQ-10020963-1