长沙招聘

Job Purpose (State in one sentence the overall objective of the job)
? Contribute in registration strategy discussion and responsible for
implementation of the planned registration strategy in China
? Compliance with applicable policies, procedures and other regulations

Major Accountabilities (Describe the main results of the job to be
achieved )
1. Be fully responsible for the registration dossier preparation and
submission of assigned projects; Be responsible for timely order the
registration sample, dossier, certificates...;
2. Contribute to the discussion of registration plan with both local and
global team;
3. Achieve the target timeline of submission and approval;
4. Track the registration status in CDE and SFDA and timely report to
the line manager;
5. Organize to answer technical questions referred by HAs;
6. Be responsible for coordinate of F2F discussion meeting with HAs;
7. Independently communicate with HQ about the issues related to the
responsible product registration; for example dealing with relative
issues on drug quality test in HA's lab;
8. Review of promotional materials and press releases for NP4
Managerial (MCC review);
9. Accountable for ensuring regulatory compliance for the responsible
brands like CMC, BPI,PSUR, RMP, registration master file and timely
update in DRAGON;
10. Monitor regulatory changes and report to line manager timely
11. Assisting line manager to coach and provide technical and regulatory
advice to junior levels if necessary;
12. Ensure regulatory activities comply with Novartis internal SOPs for
routine work;
13. Coach and provide guidance to the staff to be compliant

Key Performance Indicators (Indicate how performance will be measured: indicators, activities...)
1. Achieve the CTA/NDA submission on the targeted date;
2. Achieve the approval of CTA, NDA and other related supplementary applications on the targeted date;
3. Ensure license renewal submission and approval on time;
4. Ensure CMC/BPI/PSUR/RMP in line with SFDA regulations and Novartis internal policies;
5. Ensure registration master file update;
6. Independent coordination of f2f meeting with SFDA/CDE for new project discussion;
7. Solve the questions referred by HAs timely and smoothly;
8. Timely update and communicate the registration status to the project team;
9. Timely order and tracking the registration sample, dossier, certificates...;
10. Provide regulatory support for other functions (marketing, medical, sales, MA&C, TechOps...);
11. Keep good communication and relationship with key stake holders;
12. Participant and present on behalf of DRA in new product LRR meeting.

Ideal Background (State the minimum and desirable education and experience level)
Education:
Minimum Education:
- Bachelor degree
Desirable Education:
- Bachelor or above degree in Life Sciences, Pharmacy or Medicine, or equivalent experience
- Overseas education for master degree or PhD in Life Sciences, Pharmacy or Medicine
Languages:
- Fluency in English and Chinese (oral and written)
Experience:
Above 4 years of involvement in regulatory and drug/biologic development spanning activities in most or all of the following areas:
1. Regulatory operational expertise. Above 4 years of demonstrated accomplishment in all aspects ofregulatory affairs in a matrix environment in the pharmaceutical industry.
2. Proven success in drug regulatory submission and approval.
3. Proven ability to analyze and interpret registration efficacy and safety data in registration dossier.
4. Prior history with post-marketing/brand optimization strategies and commercial awareness preferred. Experience essential for license renewal, contingency plan for stock-up, CMC and BPI changes submission and approval.
5. Participant in HA negotiations and to provide regulatory guidance for some of the sections to demonstrate deep understanding of the reviewed project.
6. Considerable organizational awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross-functionally
7. Prior working experience in Health authority is preferred;
8. Prior Global regulatory experience in development is preferred.

北京诺华制药有限公司开发、生产和销售治疗多种疾病的创新处方药，涵盖的疾病领域包括：心血管、内分泌、肿瘤、抗感染、风湿疼痛及骨质疏松、移植免疫、中枢神经以及眼科。北京诺华制药曾获得“***雇主”和“最负社会责任的企业”等殊荣。

“诺华”中文取意“承诺中华”，即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年，总部设在北京，隶属于瑞士诺华公司。

诺华公司致力于为患者及社会提供创新医药保健解决方案，以满足其日益变化的健康需求。2011年，集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元（去除减值及摊销后为92亿美元）。诺华集团总部位于瑞士巴塞尔，业务遍及全球140多个国家和地区，拥有124,000位全职员工。诺华集团立足在中国的长期发展，重要战略投资包括位于上海的综合性生物医学研发中心，以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息，敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。