PSG Global Solutions
Associate Director of Regulatory Affairs
PSG Global Solutions, Cambridge, Massachusetts, us, 02140
Description
We're looking for an
Associate Director of Regulatory Affairs , working in the
Pharmaceuticals and Medical Products
industry in
Cambridge, Massachusetts, United States .
Responsibilities:
Works proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners (as applicable) to plan and execute global regulatory filing strategies for the company's programs across the portfolio.
Provides strategic regulatory leadership to project teams in early and late stage clinical development to advise on international filing requirements.
Leads the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle. This will include orphan designation requests, meeting briefing documents, and International Marketing Authorization Applications.
#J-18808-Ljbffr
We're looking for an
Associate Director of Regulatory Affairs , working in the
Pharmaceuticals and Medical Products
industry in
Cambridge, Massachusetts, United States .
Responsibilities:
Works proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners (as applicable) to plan and execute global regulatory filing strategies for the company's programs across the portfolio.
Provides strategic regulatory leadership to project teams in early and late stage clinical development to advise on international filing requirements.
Leads the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle. This will include orphan designation requests, meeting briefing documents, and International Marketing Authorization Applications.
#J-18808-Ljbffr