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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