We have an exciting newly created opportunity for a Regional Regulatory Therapeutic Area Lead that will be the main point of regional contact and act as the subject matter expert for strategic leadership.

In this highly visible role, you will build teams and drive their performance.

Organization: Our client is an innovator and global leading biotherapeutics organization, with a presence in over 55+ countries, 18k+ employees and a rapidly growing pipeline. They are an organization with passionate dedication to save and improve lives across the globe, now is an exciting time to join this team.

Responsibilities:

• Provide insightful scientific and regulatory leadership and vision, in developing regional regulatory strategies for the developmental portfolio.
• Collaborate with key project management, clinical development and commercial development leads to ensure successful development and execution of regulatory strategies.
• Responsible for all clinical/ safety related submissions and interaction with the FDA, and Regulatory Agencies.
• Participate in health authority meetings when needed.

Knowledge and Skills:

• A minimum of 10 years’ experience in pharmaceutical industries with at least 5 years in Regulatory Affairs.
• Experience in leading and managing teams and promoting an engaging collaborative team environment.
• Experience working in a complex and matrix setting required.
• Demonstrated knowledge of regional regulatory guidelines and legislative requirements.
• A comprehensive knowledge and understanding of pharmaceutical / biological product development and regulatory conditions for product development and approvals