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.
Requirements:
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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Full-time
举报职位
