Regulatory Project Management Specialist -- Colombia

Freyr Solutions; Bogotá; Remote; COP 60,000,000 - 120,000,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

English fluency

Project management

Cross-functional collaboration

Regulatory knowledge

Attention to detail

Education

Bachelor’s degree in Pharmaceutical Sciences or related field

Tools

Microsoft Project

Microsoft Office

Job description

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
• Detailed regulatory submission timelines
• Risks, Actions, Issues, Decisions (RAID) logs
• Rapid Response Team (RRT) activities
• 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

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

Qualifications & Experience

Education

• Bachelor’s degree in Pharmaceutical Sciences, Medical Sciences, or a related scientific discipline, or equivalent experience
• Experience
• 3–6 years of experience in the pharmaceutical or life sciences industry
• Minimum 2 years of project management experience, preferably in Regulatory Affairs or Regulatory Operations
• Experience supporting regulatory submissions for major markets (US, EU, etc.)
• Technical Skills
• Experience supporting submissions such as IND, NDA, BLA, EU MAA, EU variations
• Familiarity with regulatory project planning and submission tracking
• Experience with Microsoft Project or equivalent tools (preferred)
• Proficiency in Microsoft Office (Word, Excel, Outlook)

Soft Skills

• Strong analytical and conceptual thinking
• Ability to work effectively in a fast-paced, deadline-driven environment
• Excellent communication and interpersonal skills
• Ability to multitask and prioritize competing assignments
• Strong collaboration and stakeholder management skills
• Fluency in English (written and verbal)

What We Offer:

Competitive salary and benefits package.

Flexible work environment (remote or hybrid options available).

Opportunity to work with a global team and contribute to impactful projects.

Continuous professional growth through training and development programs.

Inclusive, collaborative, and innovative work culture.

Why Join Freyr:

Be part of a global, fast-growing organization that operates in over 150 countries.

Opportunity to work on impactful projects in a dynamic and innovative environment.

Competitive salary and benefits package, including performance-based incentives.

Flexible work options to support work-life balance.

Continuous learning and professional development opportunities.

Collaborative and inclusive work culture that values diversity.