招聘人数：1

工作地点：苏州

职位要求：

• At least four years’ experience and/or training in regulatory affairs within the Pharmaceutical industry
• Extensive experience in the Pharma industry, with direct experience of operating in many countries globally and their pharma environments
• Extensively familiar with audits –supplier audits and regulatory compliance
• Experience in tariff laws for our products and raw materials
• Continuous Improvement experience in a pharma process environment

工作责任：

• Verifies compliance with all applicable standards (e.g. ISO 9001, 15378, 13485 cGMP etc.) and assure re-certification of given standards for all kp products and sites producing PMD products
• Manage product compliance and upcoming market challenges in regards of regulatory requirements (e.g. FDA, CFDA, European Pharmacopoeia, REACH, 10/2011)
• Establish product compliance matrix for applicable legislation for all PMD sites (US, EU – food contact, pharmacopoeia, DMF, CFDA…), maintenance matrix within SAP regulatory tools
• Support global and local change control processes to ensure sustainable product and service quality and proper change management and communication to customers.
• Management of Change process for PMD sites from regulatory point of view (documentation, training, adjustments & migrations tests…)
• Work cross-functionally with Marketing and Business development to identify and manage market requirements in regards to regulatory and product compliance
• Support market communication with proactive dossiers on upcoming changes in regulatory environment
• Drive educational communication for customers on product properties and usual quality related questions in cooperation with the technical application team
• Represents kp and develops good relations with key customers and quality related regulatory authorities
• Handling of customer request concerning product compliance
• Legislation submission and annual updates of all kp Drug Master Files, China (CFDA) – preparing of dossiers for PMD products & sites
• Support in ISO certification- and customer audits at production sites
• Establish training for procurement team on regulatory requirements for sourced raw materials
• Establish training and information material for commercial team on product compliance and customer benefits

联系方式： 66605972 liuj@o-hr.cn

发布时间： 2020-04-16