About Freyr
Freyr is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences companies. With a mission to accelerate compliance and enable businesses to bring their products to market faster, Freyr operates in a dynamic, innovative, and collaborative environment. Our team of experts works on cutting-edge projects that drive meaningful impact across pharmaceuticals, biotechnology, cosmetics, food, and medical devices industries.

Job Title: Regulatory Project Management Specialist
Location: Colombia, Remote
Employment Type: Full-Time/Permanent/Indefinite

Role Overview
The Regulatory Project Management Specialist will assist in managing global regulatory projects, supporting submission activities, and ensuring effective coordination across cross-functional teams. This role will contribute to the planning, tracking, and execution of regulatory submissions while supporting Global Regulatory Teams (GRT) and Submission Working Groups (SWG) to meet regulatory milestones and timelines.

Key Responsibilities
Primary Responsibilities




• Support Submission Working Groups (SWG) by managing: SWG kick-off meetings
• Recurring SWG meetings
• Detailed regulatory submission timelines
• Risks, Actions, Issues, Decisions (RAID) logs
• Rapid Response Team (RRT) activities
• Lessons learned documentation
• Additional RPM support activities as required
• Support Global Regulatory Teams (GRT) by: Coordinating and supporting meetings
• Assisting with Regulatory Project Plans (RPP)
• Tracking GRT goals and deliverables
• Maintaining RAID logs
• Supporting additional RPM-related activities

Secondary Responsibilities
• Independently manage and support non-SWG submission types
• Provide additional regulatory project support as required

Stakeholder Interactions
• General Regulatory Teams (GRT)
• Submission Working Groups (SWG)
• Cross-functional regulatory and project teams
• External stakeholders, as applicable

Qualifications &

📌 Regulatory Project Management Specialist (Bogotá)
🏢 Freyr Solutions
📍 Bogotá