Regulatory Affairs Project Manager

Summary

Job Description

Our client, a global pharmaceutical, biotechnology, and medical technology company, is actively looking for a Regulatory Affairs Project Manager to join their team! This role is 100% remote however they are only considering candidates currently on the East Coast.

This is a 6-12 month contract with the opportunity to extend or convert based on business needs

This Project Manager will support the Global Regulatory Affairs (GRA) portfolio within a large, multi-year AI transformation across Innovative Medicine R&D. This person will help coordinate regulatory workstreams, manage project plans and dependencies, and keep deliverables on track while accounting for regulatory requirements and compliance considerations.

The role sits at the intersection of Regulatory Affairs, Data Science, and AI. The broader program is developing an integrated platform and AI-enabled products to support R&D workflows, including regulatory submissions to the FDA and other health authorities. This Project Manager will help ensure regulatory work is organized and coordinated within this evolving environment.

Responsibilities

• Coordinate project plans, milestones, risks, and dependencies across the GRA portfolio.
• Keep teams aligned on deliverables, timelines, ownership, and issues that could affect progress or compliance.
• Partner with Regulatory Affairs, Data Science, AI, and other cross-functional stakeholders.
• Support planning for regulatory requirements and compliance considerations throughout project delivery.
• Work with Veeva and develop an understanding of regulatory documentation and how it connects across relevant processes and systems.
• Help coordinate work across the broader Submission Excellence Program, which is exploring AI-enabled capabilities for FDA submission workflows.
• Communicate project status, risks, and decisions clearly to stakeholders.

Required Skills & Experience

• Project management experience in Regulatory Affairs or a closely related regulated environment.
• Working understanding of regulatory processes, compliance considerations, and the documentation involved in regulatory work.
• Experience managing schedules, deliverables, and cross-team dependencies.
• Strong stakeholder communication and organizational skills.

Preferred Experience

• Global Regulatory Affairs (GRA) experience.
• Familiarity with Veeva and regulatory documentation workflows.
• Experience supporting pharmaceutical, clinical, or life sciences projects.
• Exposure to data science, AI, or GenAI initiatives in R&D or regulated settings.

Job Description

Job Description

Our client, a global pharmaceutical, biotechnology, and medical technology company, is actively looking for a Regulatory Affairs Project Manager to join their team! This role is 100% remote however they are only considering candidates currently on the East Coast.

This is a 6-12 month contract with the opportunity to extend or convert based on business needs

This Project Manager will support the Global Regulatory Affairs (GRA) portfolio within a large, multi-year AI transformation across Innovative Medicine R&D. This person will help coordinate regulatory workstreams, manage project plans and dependencies, and keep deliverables on track while accounting for regulatory requirements and compliance considerations.

The role sits at the intersection of Regulatory Affairs, Data Science, and AI. The broader program is developing an integrated platform and AI-enabled products to support R&D workflows, including regulatory submissions to the FDA and other health authorities. This Project Manager will help ensure regulatory work is organized and coordinated within this evolving environment.

Responsibilities

• Coordinate project plans, milestones, risks, and dependencies across the GRA portfolio.
• Keep teams aligned on deliverables, timelines, ownership, and issues that could affect progress or compliance.
• Partner with Regulatory Affairs, Data Science, AI, and other cross-functional stakeholders.
• Support planning for regulatory requirements and compliance considerations throughout project delivery.
• Work with Veeva and develop an understanding of regulatory documentation and how it connects across relevant processes and systems.
• Help coordinate work across the broader Submission Excellence Program, which is exploring AI-enabled capabilities for FDA submission workflows.
• Communicate project status, risks, and decisions clearly to stakeholders.

Required Skills & Experience

• Project management experience in Regulatory Affairs or a closely related regulated environment.
• Working understanding of regulatory processes, compliance considerations, and the documentation involved in regulatory work.
• Experience managing schedules, deliverables, and cross-team dependencies.
• Strong stakeholder communication and organizational skills.

Preferred Experience

• Global Regulatory Affairs (GRA) experience.
• Familiarity with Veeva and regulatory documentation workflows.
• Experience supporting pharmaceutical, clinical, or life sciences projects.
• Exposure to data science, AI, or GenAI initiatives in R&D or regulated settings.