天津招聘

Purpose

• Support to establish regulatory CMC strategy of Post Approval Changes

filings in China (including renewal, evaluation for change requests generated at Global RegCMC, manufacturing sites etc. based on Chinese regulation and guidelines);

• Support to establish regulatory CMC strategy of CTA and NDA filings in

China for development products;

• Support to establish regulatory CMC strategy of local manufacturing

projects;

• As primary China RA representative to support China RA Head for

CMC related internal and external activities/issues.

Responsibility

• Provide CMC expertise to develop CMC strategy through all stages of drug

product development (CTA, NDA and subsequent variations, local

manufacturing etc.) according to the agreed timelines to get the approval

in China;

• Assess and communicate CMC regulatory requirements with internal

partners to ensure all CMC submissions are in compliance with applicable

regulations and guidelines;

• Update the internal stakeholders on the evolving CMC regulatory

requirements to ensure all relevant divisions/functions understand the impact and implications and take appropriate actions;

• Support RA project team for preparation of answers to questions from

Chinese Regulatory Bodies after CTA, NDA or Post Approval filing in China, and get approval according to the agreed timelines. If necessary, communicate or negotiate with Chinese Regulatory Agencies to assure timely approval.

• Support RA project team to coordinate and align with MS cross functions

to ensure adequate internal support and input in CMC related issues;

• Influence and drive regulatory CMC representation in China through

participation in industry groups such as RDPAC;

• Other supporting work assigned by China RA Head.

Requirements

• Bachelor Degree or above in chemistry, biochemistry, pharmaceutical and

biotechnology or equivalent;

• Over 10 years of experience in pharmaceutical product, proven practical

knowledge of and ability to deal with complex CMC regulatory issues and requirements;

• Excellent organizational, interpersonal and communication skills;


• Demonstrated leadership in cross-functional communication and

alignment and ownership in resolving issues;

• Demonstrated ability for strategic thinking, maintaining awareness of

business impact;

• Demonstrated alignment with cooperation values and culture;


• Fluent in Chinese and English (oral and written).

默克雪兰诺有限公司
默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。

默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。