Senior Regulatory Program Lead, Global Submissions

Planet Pharma; San Diego (CA); Remote; USD 150,000 - 195,000; Full time

Job summary

Planet Pharma in San Diego is seeking an Associate Director, Regulatory Project Manager to lead global regulatory programs for rare disease therapies, aligning milestones with program strategy and corporate priorities.

You will partner with Regulatory Affairs Strategy to create project timelines, dashboards, and cross-functional meetings while tracking commitments, submissions, and health authority interactions.

Qualifications

• Bachelor’s degree in Life Sciences or related discipline.
• 8+ years of Project Management experience in Biotech or Pharmaceutical industry.
• PMP certification is strongly preferred.
• Expertise with timeline development and management software.

Responsibilities

• Lead regulatory project management activities for global development programs, aligning plans with strategy and priorities.
• Partner with Regulatory Leads to drive Global Regulatory Team meeting operations, agendas, and action follow-up.
• Develop and manage integrated regulatory project timelines reflecting health authority milestones and dependencies.
• Oversee planning and tracking of regulatory submissions and maintenance activities (INDs, NDAs, BLAs, supplements).
• Collaborate with Regulatory Operations, Clinical Development, CMC, Biostatistics, Medical Writing, Quality, and external partners.
• Support submission planning and readiness by coordinating content planning, timelines, and review cycles.
• Create regulatory dashboards, milestone trackers, and status reports for leadership and program teams.
• Identify and mitigate regulatory risks and resource gaps affecting submission readiness and commitments.

Skills

Regulatory PM

Cross-functional leadership

Timeline management

Risk management

Education

Bachelor’s degree in Life Sciences or related discipline

MS/PharmD/PhD preferred

Tools

Smartsheets

MS Project

Job description

Planet Pharma in San Diego is seeking an Associate Director, Regulatory Project Manager to lead global regulatory programs for rare disease therapies, aligning milestones with program strategy and corporate priorities.

You will partner with Regulatory Affairs Strategy to create project timelines, dashboards, and cross-functional meetings while tracking commitments, submissions, and health authority interactions.