Regulatory Project Management Specialist - Colombia (Remote)

About the role

Freyr, a global Regulatory Solutions and Services company supporting Life Sciences companies, is hiring a Regulatory Project Management Specialist based in Colombia, working remotely. The specialist helps manage global regulatory projects, supports submission activities and coordinates cross-functional teams so that Global Regulatory Teams (GRT) and Submission Working Groups (SWG) meet regulatory milestones and timelines.

Key responsibilities

• Support SWGs by managing kick-off and recurring meetings, detailed submission timelines, RAID logs, Rapid Response Team activities and lessons learned documentation.
• Support GRTs by coordinating meetings, assisting with Regulatory Project Plans, tracking goals and deliverables and maintaining RAID logs.
• Independently manage and support non-SWG submission types and provide additional regulatory project support as required.
• Interact with GRTs, SWGs, cross-functional teams and external stakeholders.

Required profile

• Bachelor's degree in Pharmaceutical Sciences, Medical Sciences or a related scientific discipline, or equivalent experience.
• 3-6 years of experience in the pharmaceutical or life sciences industry.
• At least 2 years of project management experience, preferably in Regulatory Affairs or Regulatory Operations.
• Experience supporting regulatory submissions for major markets such as the US and EU.
• Fluency in English, written and spoken.

Required skills

• Experience with submissions such as IND, NDA, BLA, EU MAA and EU variations.
• Familiarity with regulatory project planning and submission tracking.
• Microsoft Project or equivalent tools (preferred).
• Proficiency in Microsoft Office (Word, Excel, Outlook).
• Analytical thinking, strong communication, multitasking and stakeholder management.

What we offer

• Competitive salary and benefits package, including performance-based incentives.
• Flexible work environment with remote or hybrid options.
• Training and development programs and continuous professional growth.
• A global, collaborative and inclusive work culture.