- Regulatory Project Manager - Colombia

Freyr Solutions; Bogotá ciudad; A distancia; COP 280.260.000 - 404.820.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible work options

Global exposure

Descripción de la vacante

Freyr Solutions is seeking a Regulatory Project Manager (RPM) to support global regulatory submissions and coordinate cross-functional teams in a remote, fast-paced environment. You will help plan, track, and execute campaigns across major markets, collaborating with GRT, SWG, and RRP stakeholders.

The ideal candidate has 4–6 years in pharma or life sciences, at least 2 years of project management experience, and hands-on experience with US/EU submissions.

Formación

• Bachelor's degree in Pharmaceutical or related field.
• 4–6 years in the pharma or life sciences industry.
• Minimum 2 years of project management experience.
• Experience supporting regulatory submissions for major markets (US, EU).

Responsabilidades

• Manage SWG kick-off meetings and recurring SWG meetings.
• Develop detailed regulatory submission timelines and RAID logs.
• Coordinate GRT activities and RPP development.
• Track goals, deliverables, and RAID logs for regulatory submissions.
• Provide RPM support for non-SWG submissions.

Conocimientos

Analytical thinking

Communication skills

Multitasking

Stakeholder management

English fluency

Educación

Bachelor's degree in Pharmaceutical Sciences or related field

Herramientas

Microsoft Project

Microsoft Excel

Microsoft Word

Regulatory submission tracking

Descripción del empleo

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.