- Regulatory Project Manager - Colombia

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 Manager (RPM) Support

Location: Remote

Employment Type: Full-Time/Permanent/Indefinite

Role Overview

The Regulatory Project Manager (RPM) Support 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

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

Experience

4-6 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.

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