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Regulatory Affairs Manager
- Permanent
- Senior/Director & VP
- United Kingdom
This vacancy has now expired. Please see similar roles below...
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.
Job Responsibilities
- 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.
To Apply
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.
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