Remote Regulatory Project Lead - Submissions and Strategy

Freyr Solutions; Bogotá; Remote; COP 60,000,000 - 90,000,000; Full time

Benefits offered by this job

Competitive salary and benefits

Flexible remote or hybrid options

Global team exposure

Training and development programs

Collaborative culture

Job summary

Freyr Solutions is seeking a Regulatory Project Management Specialist in Colombia (Remote) to drive global regulatory submissions. You will coordinate cross-functional teams, manage timelines, and maintain RAID logs to ensure milestones are met.

The role requires 3–6 years in life sciences with at least 2 years in project management, plus experience in major market submissions (US, EU) and proficiency with MS Project/MS Office. Remote or hybrid options available.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Medical Sciences, or related field.
• 3–6 years of experience in the pharmaceutical or life sciences industry.
• Minimum 2 years of project management experience, preferably Regulatory Affairs/Operations.
• Experience supporting regulatory submissions for major markets (US, EU, etc.).
• Experience with regulatory project planning and submission tracking.

Responsibilities

• Support SWG by managing kick-off meetings and recurring sessions.
• Maintain detailed regulatory submission timelines and RAID logs.
• Coordinate RAID, RRT activities, and lessons learned documentation.
• Assist with Regulatory Project Plans (RPP) and tracking GRT goals.
• Provide support for non-SWG submission types as needed.

Skills

Fluency in English

Analytical thinking

Communication skills

Multitasking

Stakeholder management

Education

Bachelor’s degree in Pharmaceutical Sciences or related discipline

Tools

Microsoft Project

Microsoft Office

Job description

Freyr Solutions is seeking a Regulatory Project Management Specialist in Colombia (Remote) to drive global regulatory submissions. You will coordinate cross-functional teams, manage timelines, and maintain RAID logs to ensure milestones are met.

The role requires 3–6 years in life sciences with at least 2 years in project management, plus experience in major market submissions (US, EU) and proficiency with MS Project/MS Office. Remote or hybrid options available.