长沙招聘

Major Accountabilities
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. Coordinate of F2F discussion meeting with HAs;
7. 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. Assist line manager to coach and provide technical and regulatory advice to junior levels if necessary (CMC, BPI, PSUR, RMP operational...;
12. Ensure regulatory activities comply with Novartis internal Code of Conduct and SOPs during routine work;

Ideal Background

Education: Minimum Education:
Bachelor degree
Desirable Education:
Bachelor or above degree in Life Sciences, Pharmacy or Medicine, or equivalent experience
Overseas education for master or PhD in Life Sciences, Pharmacy or Medicine

Languages: Fluency in English and Chinese (oral and written)

Experience:
Above 2 years of involvement in regulatory and drug/biologic development spanning activities in most or all of the following areas:
1. Regulatory operational expertise. Above 3 years of demonstrated accomplishment in some aspects of regulatory affairs in a matrix environment in the pharmaceutical industry.
2. Proven experience in drug regulatory submission and approval, such as CMC, BPI, license renewal, import CTA/NDA...;
3. 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.
5. Participant in HA negotiations;
6. Prior working experience in Health authority 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。