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.