Description
Regulatory Affairs Specialist - Contract - Asia Pacific
Senior Regulatory Affairs Specialist opportunity has arisen to work with a large Pharmaceutical organisation. Regulatory Affairs Expert required to support the strategic development of a new Global Repository System. They`re looking for someone to take on a customer facing role in their region ensuring all data collected is appropriate and correct to populate the database The Regional Master Data Expert will support assembly, strategic development, and maintenance of a database for CMC, Trade, Artwork/Labeling, Supply Chain and Regulatory requirements.
Roles and Responsibilities:
. Supporting the Data Collection and maintenance activities
. Liaising with Regulatory Affairs Managers and SME`s to confirm all data is appropriate for entry
. Focusing on the integration of the system and data thereof
. Managing the project in your region and the respective Regulatory Managers
. Training internal customers to use and maintain the system
. Based from home but required to travel 80-90% of the time.
Requirements:
. Bachelors or Science degree
. Minimum of 5 years in Regulatory/CMC environment - more experience preferred
. Experienced in either drugs or medical devices regulatory environments
. Minimum of 5 years Post Approval experience
. Experience building customer relationships
. Comfortable working with Microsoft Excel
. Strategic mindset for development of the Regulatory Master Data repository that will transform how they support regulatory activities
Please note you will be required to travel within your selected region for this role.
Please apply today with your CV and a covering letter highlighting your key skills and relevant experience aligned to this opportunity.