An internationally known biotechnology company has an opening for a Regulatory Affairs Manager to represent China's products from their Berkshire office. This company has a strong reputation for developing innovative therapies.
Member of regulatory project team(s) representing the China for 1-3 development/marketed products Work with global clinical development and R&D teams to prepare regulatory documentation to support regulatory engagement and NDA submissions in China. Attend global regulatory, cross-functional R&D and asset level business meetings to provide strategic direction and scientific rationale for regulatory activities required to support clinical trials and marketing applications in China. Provide oversight of local operational activities required to make regulatory applications in China, via CRO and company affiliate. Maintain close collaboration and partnership with China/regional business colleagues, up to and including President of APAC, in addition to local medical and clinical operations colleagues.
Skills and Requirements
Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals. Demonstrate strong organizational skills, including the ability to prioritize personal and junior team member's workload. Demonstrate effective cross-cultural awareness and capabilities. Seeking colleagues capable and experienced enough to manage multiple and confounding activities at once. Confident to identify and acknowledge when management support is required to prioritize or drive activities to a resolution.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.