药品注册-C

Responsibilities
• Manages, prepares and submits regulatory applications within specified timeline in China.
• Undertake interactions and negotiations with regulatory authorities to secure and optimize regulatory approvals concordant with strategic company goals.
• Plans and prioritizes maintenance activities and regulatory variations to ensure compliant with China regulatory requirements.
• Reviews labeling and packaging, promotional and educational materials in line with regulatory and company compliance requirements.
• Assistant to the regulatory manager helps to interacts with Global/regional development team to achieve strategic company goals.
• Assistant to regulatory manager, provides information to the assigned project planning and regulatory strategic plans in cooperation with global/regional/local staff to achieve and optimize strategic company goals
• Keeps up-to date with government legislation relating to regulatory affairs in China.
• Contributes to company systems development, maintain regulatory document management systems.
• To carry out any other tasks assigned by the line manager.
Education:
• Bachelor degree in pharmacy
Experience & knowledge:
• Mimimum 1 years experience in registration field
Core competencies:
• Good computer skill in EXCEL, POWERPOINT and WORD
• Good interpersonal communication skill
• English skill both in spoken and written
关键词：进口药，NDA，国内注册