Associate Global Regulatory Manager, GRSS&C

About the role

Responsible for managing regulatory clinical trials or maintenance activities under supervision, the aGRM-RACS focuses on the delivery of regulatory activities related to clinical trial applications or to the maintenance of the assigned portfolio for selected countries/region.

What you'll do

• Manage assigned product portfolio and country / region knowledge
• Use regulatory expertise and knowledge to identify issues, gaps, and tradeoffs to avoid/minimize delays and achieve timely submission and approvals
• Manage timely responses to HA queries and collaborate with regulatory lead to preparing strong justifications to address regulatory gaps
• Responsible for appropriate entering of product specific attributes in compliance database and applicable RIMs
• Facilitate preparation and finalization of documents for HA interactions for matters of low complexity

What you need

• 5–9 yrs of experience
• Compliance
• Regulatory affairs
• Clinical research
• M.Pharm or PhD