【招聘】Regulatory Affairs Manager / 法规事务经理
为了实现赛诺菲在中国市场的领先地位及多元化的业务发展模式,优秀的员工是我们长期成功发展的关键。公司目前有如下职位正在招聘,我们诚邀您的推荐或申请。如果您对以下职位感兴趣,或者有合适的外部候选人,请将简历在2012-12-12前发至nana.ge@sanofi.com。
Working Location 工作地:
Beijing
KEY ACCOUNTABILITIES 关键职责:
· Set up action plan and monitor process for regulatory activity, e.g. tracking registration activities on documents preparation, submission and approval;
· Proactively manage the license renew, CMC changes for the marketed products;
· Provide regulatory inputs to new project registration strategy in China;
· Review promotional materials;
· Provide with creative and innovative solution to address difficult regulatory issues;
· Full compliance with all government regulations and Genzyme policies including oversight of corrective actions
· Regularly report to RA international and regional about the updated product registration status;
· Establish and maintain a good relationship with the internal and external stakeholder.
· Provide regulatory supports to marketing and sales team;
JOB-HOLDER ENTRY REQUIREMENTS 基本要求:
Profile and experience
· At least 5 years working experience in regulatory affairs, both in biological and chemical products
· Proven ability to manage complex regulatory issues;
· Proven ability to consistently deliver to time, cost and quality standards;
· Good communication skill, creativity and problem thinking skill, objective driven;
· Good command of English in both writing and speaking;
· Maintain good relationship with local HAs.
· A team player, open-minded
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