US Regulatory Submissions Program Manager

Freyr Solutions; Canada; On-site; CAD 90,000 - 130,000; Full time

Job summary

Freyr Life Sciences in Canada is seeking an experienced Regulatory Project Manager with US submissions experience to lead global filings from planning through approval. You will coordinate cross-functional teams, manage timelines, and communicate with stakeholders to ensure timely submissions.

The role requires 8–15 years in regulatory affairs, independent submission management, and the ability to create study plans, dashboards, and risk logs while maintaining compliance across markets.

Qualifications

• Experience managing regulatory submissions for global filings.
• Ability to lead cross-functional teams and manage timelines.
• 8–15 years of regulatory submissions experience or equivalent.

Responsibilities

• Independently manages submissions and supports RPM during major filings.
• Co-leads SWGs with regulatory leads for global markets.
• Develop timelines and maintain submission lifecycle schedules.
• Prepare agendas, gather inputs, and track actions and decisions.
• Create and maintain submission timelines and documentation plans.

Skills

Regulatory submissions management

Project management

Cross-functional coordination

Tools

MS Project

Smartsheets

MS Word

MS Excel

Outlook

Job description

Freyr Life Sciences in Canada is seeking an experienced Regulatory Project Manager with US submissions experience to lead global filings from planning through approval. You will coordinate cross-functional teams, manage timelines, and communicate with stakeholders to ensure timely submissions.

The role requires 8–15 years in regulatory affairs, independent submission management, and the ability to create study plans, dashboards, and risk logs while maintaining compliance across markets.