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ASPAC Regional RA Manager

This job posting is no longer active.

Location: Seoul, Korea, Republic of
Position Type: Unfixed Term
Job Function: Regulatory Affairs

RA Regional manager ASPAC

 

Primary Purpose and Overall Objective of the Job:

Lead and coordinate all regulatory affairs activities in the region

Reporting to group Regulatory Affairs Market and functionally to the  Senior VP Clinical Operations ASPAC

Main Accountabilities:

  • Develop, drive, and implement regulatory strategy for all countries of ASPAC region (except China)
  • Lead and ensure successful and timely execution of RA submissions (subsidiaries and distributors) in order to secure approvals and to support clinical and industry business
  • Play strategic interface with country/functions and act as active member of the ASPAC Leadership Team
  • Ensure coordination with all Global Teams (RA Market, BioFire, LCM, TPP, Industry RA)
  • Facilitating alignment between Global / Regional / local marketing and Registration plan
  • Analyze and drive RA process efficiency, escalate needs and issues, as needed
  • Manage performance of local RA teams, training & development
  • Participation to Industry association (APACMED, MECOMED…) and communication

 

Studies experience

  • Scientific background with knowledge and deep understanding of regional regulatory requirements
  • More than 8 years of practice in regulatory affairs in an international environment
  • Experience in a management position

Skills

  • Ability to lead cross-cultural and transversal groups
  • Strong leadership skills and experience, ability to build collaborative relationships to meet corporate goals
  • Strong communication skills
  • Strategic thinking and problem solving approach
  • Ability to drive change and influence decision
  • Fluent English

 

Preferred Location : Shanghai, Hong Kong or Singapore

Business travels required across the region.

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