ASPAC Regional RA Manager

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.