Freyr Life Sciences; The Largest Integral Regulatory Solutions & Services Provider, Supporting, Large, Mid & Small global Life Sciences companies, (Pharmaceutical | Generics | Medical Device | Consumer Healthcare | Cosmetics | Biotechnology | Chemicals | Biosimilar | Biocides) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related function.

Regulatory Consulting & Strategy, Regulatory Operations & Affairs, Regulatory Software Solutions, Regulatory Information & Intelligence, Global Regulatory Responsibility Services, Regulatory Publishing & Submission, Regulatory Medical Writing, IDMP, Medical Devices Regulatory Services, Regulatory Artwork & Labeling, CMC, Medical Devices, Pharmaceutical, Biotechnology, Biosimilar, Cosmetics, Consumer Healthcare, OTC, Regulatory Intelligence, food supplements, Global Regulatory Affairs, Labeling, Artwork, chemicals, eCTD, and Regulatory software solutions

Job title: Regulatory Project manager





Job Type: Permanent/Full-time/Indefinite

Work Location: Bogota, Colombia (Remote)

Description:

Experience: 5 - 10 years
- Independently manages submissions (and supports internal RPM in managing initial major global filings).
- Co-leads SWGs with the designated regulatory lead for non-major global markets MAAs and supplements
- Work with functional sub-teams to develop timeline based on data availability and other critical path activities. Identify critical path to submission. Maintain timeline during project lifecycle.
- Schedule kick off meeting.
- Ensure appropriate representation from needed cross-functional team members.
- Create draft agenda with GRL/EMRL or Reg Lead and work with cross-functional team to gather presentations. Provide agenda for kick off prior to meeting.
- Facilitate Kick Off. Represent Project Management at Kick Off (i.e., present timelines, SWG overview,

📌 Colombia - Regulatory Project Manager
🏢 Freyr Solutions
📍 Colombia