Global Regulatory Project Lead

Barrington James; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Barrington James is seeking a seasoned Regulatory Affairs professional to drive global submissions and timelines for commercial products. You will partner with cross-functional teams to ensure filings align with market plans and health authority expectations.

You will co-lead GRPT meetings, coordinate NDA/BLA/MAA submissions, manage risks, and maintain dashboards and reports to support launch readiness and lifecycle management.

Responsibilities

• Partner with cross-functional teams to develop regulatory timelines and strategies for commercial products.
• Co-lead Global Regulatory Project Team (GRPT) meetings with the GRL for launch and lifecycle activities.
• Co-lead filing teams for NDA/BLA/MAA submissions and labeling updates to meet timelines.
• Identify regulatory risks, escalate issues and propose mitigation strategies.
• Prepare and maintain submission timelines, trackers and dashboards.
• Document decisions, actions, and risks in designated repositories.
• Support process standardization and dashboard improvements for submission workload management.

Job description

Barrington James is seeking a seasoned Regulatory Affairs professional to drive global submissions and timelines for commercial products. You will partner with cross-functional teams to ensure filings align with market plans and health authority expectations.

You will co-lead GRPT meetings, coordinate NDA/BLA/MAA submissions, manage risks, and maintain dashboards and reports to support launch readiness and lifecycle management.