Associate Director/Director Regulatory Affairs - China/Japan Liason

Regulatory Professionals
East Horsley
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Associate Director/Director Regulatory Affairs - China/Japan Liason Location: Cambridge Salary: Excellent base salary and flexible benefits Job Ref:J30732 Regulatory Professionals are working with a well-established and respected pharmaceutical company who are looking for an Associate Director or Director to liaise with their Chinese and Japanese Regulatory agencies. The company provide strategic support to pharma and biotech companies on a global scale and has a network stretching across over 50 companies worldwide. Main Responsibilities: * Validate strategy and planning for IND and NDA Applications for CFDA/ PMDA submissions * Establish and build relationships with China/Japan Regulatory Affairs through regular meetings * Develop best practices for the company's research and development to assist in agency interactions * Represent the company both internally and externally * Actively network in the regulatory field to identify and improve ways of working * Advise Regulatory Affairs Leads and Regulatory Operations of dossier and submission requirements for China/ Japan * Participate in project teams, provide strategic guidance for research and marketed products Application Requirements: * Ability to communicate in Chinese and/or Japanese is essential * Science degree or equivalent * Breadth of technical regulatory knowledge and experience of working with Chinese and Japanese regulatory submissions * Ability to negotiate and influence internal and external bodies * Proven experience of responsibility and accountability for managing and delivering regulatory projects * Strategic thinking and capability of building effective working relationships Japan, China, strategy, advice, regulatory, Cambridgeshire, submissions, CFDA, PMDA