05 ago
|
Freyr Solutions
|
Bogotá
05 ago
Freyr Solutions
Bogotá
About Freyr
Freyr is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized general 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 & E
📌 Colombia - Regulatory Project Manager (Bogotá)
🏢 Freyr Solutions
📍 Bogotá