Global Regulatory Program Manager – Oncology

Medasource; Raritan (NJ); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid work

On-site 2-3 days/week

Job summary

Medasource is seeking an experienced Regulatory Program Manager to support global oncology programs within a large pharmaceutical organization.

The role partners with Global Regulatory Leaders and cross-functional teams to translate regulatory strategy into executable program plans and drive global submissions across the development lifecycle.

Qualifications

• Experience in drug development and global Regulatory Affairs.
• Oncology program experience preferred.
• Experience with major regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs).
• Experience partnering with Global Regulatory Leaders and Teams.
• Strong PM skills: integrated timelines, critical path, risks, scenario planning.

Responsibilities

• Translate regulatory strategy into integrated project plans and actionable execution strategies.
• Develop and manage detailed regulatory timelines, critical paths, milestones and risks.
• Provide PM leadership to Global Regulatory Teams and governance meetings.
• Coordinate regulatory activities across Clinical, CMC, Medical Writing, Regulatory Operations and other stakeholders.
• Lead global regulatory submissions planning and execution (INDs, CTAs, NDAs, BLAs, MAAs).
• Coordinate submission activities and Health Authority milestones; support filing/launch sequencing.

Skills

Global Regulatory

Oncology programs

Regulatory submissions

Project management

Cross-functional teams

Stakeholder management

Communication

Tools

Microsoft Project

Planisware

OnePager

Office Timeline

Lucid

Job description

1 year contract with high probability of extensions

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

ASAP start

Position Overview

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.

Key Responsibilities

• 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.

Qualifications

• 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.

Preferred Tools

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