南京招聘

Dimensions of Job:

 

Regulatory compliance support for Quality Management System building

Labelling End to End labelling process optimization and operation excellence to support new product launch acceleration and marketed products compliance

Regulatory process development & resource planning

 

 

Principal Accountabilities of Job:

 

Regulatory compliance oversight and support for Quality Management System building, including development of RA compliance plan and quality metric, and contribution to quality system of Business quality, R&D quality, Site quality and others

Drive internal regulatory process development to reflect internal process and external legislation change, including labelling E2E process optimization, to reflect regulatory environment change, business model changes, and to mitigate identified gaps.

Driving system compliance and data accuracy, including new system launch readiness.

Leading China RA record Management, to ensure timely record archiving and retention, to support product LCM

Credo based behavior with regulatory compliance excellence

Key Performance Measures:

 

RA quality metrics are well defined and implemented

Labelling process high efficiency and AW high quality

No critical finding

Cross-team connection and leadership

 

 

 

 

Qualifications & Competencies:

 

A bachelor degree major in chemistry, pharmaceutics, biology or a related life-science discipline. A master degree or above is preferable.

Minimum of 2 years’ experience in a multinational pharmaceutical company, relevant compliance management working experiences is preferable.

Strong oral & written communication skill; good leadership capability and ability to work under pressure. Demonstrated ability to effectively manage.

Have knowledge of regulations and guidelines, esp. labelling

Proficiency in verbal and written English; good computer skill, good presentation skill.

  

万宝盛华大中华有限公司，1997年服务启航于香港和台湾。迄今服务覆盖上海、北京、广州、深圳等逾20座直营城市。我们的大股东万宝盛华全球（ManpowerGroup Inc. NYSE:***）是全球人力资源解决方案领导者，拥有70年服务经验。凭借万宝盛华全球的声誉及行业经验，万宝盛华大中华深耕本土20余年。2015年，万宝盛华大中华战略联盟中信产业基金，总部落地上海，服务网络覆盖两岸三地130余城市逾两万家企业。我们始终致力于释放人才的发展潜能，凭借灵活用工、人才寻猎、招聘流程外包、人才管理及培训发展等人力资源综合解决方案，广受业界赞誉，屡次荣膺“亚太人力资源领军企业”。