Associate Regulatory Affairs Manager

• Assist the team to obtain the PIC/S GMP certification.
• Monitor regulatory requirements and emerging trends in relevant markets. Provide actionable insights to the company regarding regulatory changes and their implications.
• Serve as point of contact for internal and external partners to ensure partnership goals are achieved and governance processes are respected.
• Assists in the definition of deliverables, requirements, expectations, and help set realistic targets/timeframes for different scenarios involving Clinical, Manufacturing, and Regulatory Affairs which can differ dramatically between the US, EU and Asia.
• Facilitates professional communication with internal and external stakeholders to ensure projects milestones are met, escalates as needed to deliver collaboration goals.
• Develops and maintains a comprehensive knowledge of each alliance partner and maintain timelines for deliverables and key milestones.
• Assist the management, with eventual development into leading, of a dynamic, fast-paced, and highly regulated projects throughout an international environment
• Distills and documents discussions and outcomes as meeting minutes for senior management to execute key business decisions.
• Perform other assigned tasks as needed.

• Degree in Medical Sciences or related discipline
• Strong knowledge of PIC/S GMP manufacturing and regulatory regulations and requirements for pharmaceutical/biological products.
• 2-3 years in a project management, regulatory compliance or alliance management function covering the China markets.
• Experience in working at GMP biopharmaceutical or pharmaceutical manufacturing field is an advantage
• Ability to stay updated on regulatory changes and industry trends.
• Working experience in a highly regulated field and communication with external internal partners is a plus
• Fluent in both Mandarin and English languages (verbal, written and translation ability)
• Flexible working hours to meet geographical needs – occasional early days and late evenings are expected
• Ability to travel cross-border.
• Microsoft office (including powerpoint and excel)
• Ability to coordinate requests, meetings, and events
• Ability to prepare reports, proofread documents
• Experience in professional communication with external partners is preferred

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