Remote Global Regulatory Project Manager

Freyr Solutions; Bogotá; Remoto; COP 60.000.000 - 120.000.000; Tempo pieno

Descrizione del lavoro

Freyr Solutions in Colombia (remote) is seeking a Regulatory Project Management Specialist to support global regulatory projects, coordinating submission activities and timelines with Global Regulatory Teams and SWGs.

You will manage RAID logs, RRT activities, and contribute to Regulatory Project Plans, ensuring milestones across US, EU and other major markets, with 3–6 years in pharma and at least 2 years in project management.

Competenze

• Bachelor’s degree in pharmaceutical sciences or related discipline.
• 3–6 years of experience in pharma or life sciences.
• Minimum 2 years of project management experience.
• Experience supporting regulatory submissions for major markets (US, EU).
• Experience with regulatory project planning and submission tracking; MS Project preferred.

Mansioni

• Support Submission Working Groups (SWG) with kick-off meetings and detailed submission timelines.
• Maintain RAID logs and support RAID process.
• Coordinate Global Regulatory Teams (GRT) meetings and assist with Regulatory Project Plans (RPP).
• Track GRT goals and deliverables and ensure milestones.
• Support non-SWG submissions and provide regulatory project support as needed.

Conoscenze

English fluency

Project management

Cross-functional collaboration

Regulatory knowledge

Attention to detail

Formazione

Bachelor’s degree in Pharmaceutical Sciences or related field

Strumenti

Microsoft Project

Microsoft Office

Descrizione del lavoro

Freyr Solutions in Colombia (remote) is seeking a Regulatory Project Management Specialist to support global regulatory projects, coordinating submission activities and timelines with Global Regulatory Teams and SWGs.

You will manage RAID logs, RRT activities, and contribute to Regulatory Project Plans, ensuring milestones across US, EU and other major markets, with 3–6 years in pharma and at least 2 years in project management.