Regulatory Affairs Manager

Major Responsibilities：

• Manages, prepares and submits regulatory applications& questions within specified timeline in China
• Undertakes interactions and negotiations with Regulatory Authorities to secure and optimise regulatory approvals concordant with strategic company goals.
• Plans and prioritises maintenance activities and regulatory variations to ensure products comply with conditions of registration, China regulatory requirements.
• Reviews labelling and packaging, promotional and educational material in line with regulatory requirements.
• Interacts with personnel from overseas offices and HQ to achieve strategic company goals and provide advice on China requirements.
• Participates in project planning and regulatory strategic plans in cooperation with local company personnel and HQ staff to achieve and optimise 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

Requirement：

• Degree in pharmacy, science, biomedical/life science.  Higher degree desirable
• 5-7 years regulatory affairs experience in the prescription pharmaceutical area.
• Experience with new chemical entities (NCE) and/or biopharmaceutical applications, knowledge and understanding of drug development processes.  Preferably with a multinational pharmaceutical company.
• Prefer about 3 y bio-product experience, with good understanding of biological registration process
• Experience with China regulatory affairs processes.