Global Regulatory Program Manager – Oncology

1 year contract with high probability of extensions

hybrid in Spring House, PA OR Raritan, NJ (2-3 times onsite per week)

ASAP start

We are seeking an experienced Regulatory Program Manager to support global oncology programs within a large pharmaceutical organization. This individual will partner closely with Global Regulatory Leaders, Global Regulatory Teams (GRTs), and cross-functional development teams to translate regulatory strategy into detailed, executable program plans.

The Regulatory Program Manager will drive integrated timelines, regulatory milestones, risks, dependencies, global submission activities, and team execution across the development lifecycle.

• Partner with Global Regulatory Leaders and cross-functional teams to translate global regulatory strategy into integrated project plans and actionable execution strategies.
• Develop and manage detailed regulatory timelines, including critical paths, dependencies, milestones, risks, and mitigation plans.
• Provide project management leadership to Global Regulatory Teams (GRTs) and support effective execution of global regulatory strategies.
• Facilitate GRTs, Submission Working Groups, Rapid Response Teams, and other regulatory governance meetings, ensuring clear decisions, actions, ownership, and accountability.
• Coordinate regulatory activities across Clinical, CMC, Medical Writing, Regulatory Operations, and other cross-functional stakeholders.
• Lead operational planning and execution for global regulatory submissions, including INDs, CTAs, NDAs, BLAs, MAAs, clinical variations, and other major submissions.
• Coordinate worldwide submission activities and support filing/launch sequencing, pre- and post-submission activities, and Health Authority interactions and milestones.
• Facilitate scenario planning, risk assessments, and development of decision-support materials to enable timely program decisions.
• Partner with Compound Development Teams (CDTs), senior stakeholders, co-development partners, and external teams to maintain alignment across regulatory programs.
• Support regulatory budget planning, resource forecasting, cost tracking, and portfolio planning activities.

• Previous experience supporting pharmaceutical drug development and global Regulatory Affairs programs.
• Experience supporting oncology programs strongly preferred.
• Demonstrated experience with major regulatory submissions such as INDs, CTAs, NDAs, BLAs, and/or MAAs.
• Experience partnering with Global Regulatory Leaders and/or Global Regulatory Teams.
• Strong project/program management experience, including development of integrated timelines, critical-path management, dependencies, risk mitigation, and scenario planning.
• Experience coordinating complex global, cross-functional teams and driving execution against major regulatory milestones.
• Strong communication, stakeholder management, organizational, and facilitation skills.

Experience with Microsoft Project strongly preferred. Additional experience with Planisware, One Pager, Office Timeline, and/or Lucid is a plus.