Regulatory Affairs Manager

Highly Competitive
  1. Permanent
  2. Senior/Director & VP
  3. United Kingdom
Berkshire, England
Posting date: 08 Sep 2020
31649

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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