Regulatory Affairs Project Manager

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

• Partner across cross-functional project teams to develop and deliver regulatory timelines and strategies for commercial products, enabling successful marketing applications and post-approval filings with Global Health Authorities.
• Co-lead Global Regulatory Project Team (GRPT) meetings with the GRL for marketed and late-stage products, focusing on execution, issue resolution and timeline adherence across launch and lifecycle activities.
• Co-lead product and submission-specific, multi-disciplinary Filing Teams for commercial submissions (e.g. NDA/BLA/MAA, supplements, line extensions, variations and labeling updates), working with key contributors to set expectations, coordinate deliverables and meet timelines.
• Proactively drive commercial project and submission teams, setting the right level of urgency and accountability for deliverables tied to launch, market-access and lifecycle milestones.
• Develop and actively manage project timelines and integrated submission plans for commercial filings so milestones stay on schedule and align with commercial launch and supply plans (MS Project).
• Work with functional representatives to understand individual deliverables and interdependencies, and build and maintain an overall project timeline across Modules 1–5, including region-specific Module 1 and post-approval CMC and labeling requirements.
• Prepare and distribute routine reports, trackers and dashboards on commercial submission status and upcoming milestones.
• Track high-level commercial submission activity and Health Authority interactions to support Regulatory resource planning.
• Identify and communicate regulatory and project risks to commercial filings, escalate issues, and propose mitigation strategies to cross-functional teams and management as appropriate. Prepare meeting agendas and minutes, document decisions and action items, and track risk mitigation plans; organize and maintain this information in designated repositories.
• Contribute to standardizing and continuously improving processes and dashboards that support management of the commercial submission workload.