Regulatory Affairs Manager (China - Beijing)
 
Job Responsibilities:
• Set up registration plan for new product in China;
• Prepare, submit and follow the application for new drug registration on time;
• Prepare applications for variations of marketed products and license renewals within the set time frame;
• Well know professional registration knowledge on Chinese regulations or guideline;
• Take an active role in building and maintaining relationship with regulatory authorities;
• Track new regulations / standards or changes and evaluate the business impact to commercial or company.
Qualifications:
• Bachelor degree or above, majored in a Pharmacy or similar background.
• A minimum of 3 years experience in the regulatory affairs.
• Good understanding of local regulations, guidelines and requirements and have experience in preparation of submissions.
• Good oral and written English communication skills.
• Good communication and team cooperation skill.
• Effective problem solving, organizing and planning capabilities.
 
Primary Location：
Beijing