北京招聘

This role will be accountable for regulatory strategy development, be accountable for he implementation of the registration strategy in China, complaincem with applicable policies, procedures and other regulations.

Your Responsibilities：

1.    Provide regulatory inputs in new project development strategy discussion;

2.    Lead or coordinate both local and global team on registration plan;

3.    Be accountable on the implementation the decided project registration strategy by projects planning and tracking  

4.    Be accountable on achieving the target timeline of submission and approval;

5.    Be accountable on the communication with HAs to properly address the concerns on projects; and the coordination on related HA meetings;

6.    Be accountable on the communication with Global team on the related regulatory issues on the responsible projects. 

7.    To solve the regulatory issues via communication and negotiation with HAs if necessary

8.    Review/approve of promotional materials and press releases for NP4 Managerial (MCC review);

9.    Lead or chair the CPT meetings for responsible project and be accountable to provide regulatory support to other functional team;

10.  Contribute to optimize DRA internal operational procedures whenever is needed

11.  Be accountable for ensuring regulatory compliance for the responsible brands like CMC, BPI，PSUR, RMP, registration master file and timely update in DRAGON;

12.  Ensure regulatory activities comply with Novartis internal Code of Conduct and SOPs/WIs during routine work;

13.    Monitor regulatory changes and report to department head timely

14.    Support line manager to control project cost according to budget

15.    coach the junior levels ;

16.    Acting as deputy in  the absence of the department head and lead team daily operation

What you’ll bring to the role:

• Bachelor or above with Pharmaceutical/Medical background
• Fluency in English and Chinese  (oral and written)

Desirable 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;
• The experience in oncology product submission is a plus

You’ll receive:

Competitive salary, annual bonus, pension scheme, health insurance, flexible working arrangements, subsidized dining facilities, employee recognition scheme.

Why consider Novartis?

750 million. That’s how many lives our products touch. 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 determinationto tackle the world’s toughest medical challenges. 

We are Novartis. Join us and help us reimagine medicine.

诺华（Novartis AG）是全球医药保健行业的领导者。其核心业务涉及专利药，非专利药，眼睛护理，消费者保健和动物保健等领域。诺华公司总部设在瑞士巴塞尔，业务遍及全球140多个国家和地区。

诺华（中国）生物医学研究有限公司是诺华全球研发组织――诺华生物医学研究所（NIBR）的第八个研究基地。我们位于中国上海市张江高科技园区，将成为诺华在亚洲的主要研究中心，以及除在欧美的研究中心外的最主要的研究中心。我们的研究和探索开发活动的重点是发现并开发创新疗法，用于治疗在亚洲远未达到医药需求的疾病。我们与从不同之处在于将专注现代药物的发现和开发方法的研究。最初阶段，研发工作将专注在引起中国地方性癌症的感染原因。我们还将开展临床试验，进行安全性研究，生物标志物和检测分析，表达谱、生物分析以及转化医学的研究。

随着公司业务的迅速扩展，我们热忱欢迎您的加入。同时我们将提供具有竞争力的薪酬福利待遇以及良好的培训发展机会。