About Freyr
Freyr Colombia SAS 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.

At Freyr, we believe in fostering talent and creating an inclusive work culture where employees are empowered to succeed. Join a company that values innovation, integrity, and the power of collaboration.

Job Title: Team Lead – Regulatory Affairs (CMC / Lifecycle Management)
Location: Bogotá, Colombia
Job Type: Full-time Employee

Responsibilities
• Perform and review Change Control impact assessments and define integral variation submission strategies.
• Prepare and finalize variation and renewal packages for global Health Authorities (EU, APAC, Africa, MENA, LATAM).




• Track post-approval and renewal submission plans to ensure timelines are met.
• Provide strategic guidance and review support for Health Authority query (HAQ) responses.
• Conduct gap analyses and prepare dossiers for global market expansion, advising on country-specific requirements.
• Coordinate with stakeholders and local RA teams for supporting documents, CPPs, legalization, and apostille.
• Lead cross-functional team meetings and manage large global regulatory programs.

Required Skills
• Master’s degree in Pharmacy or Life Sciences.
• 4–8 years of experience in CMC Regulatory Affairs and lifecycle management.
• Strong experience in CMC authoring, change control management, variations, and renewals.
• In-depth knowledge of global and country-specific regulatory requirements.
• Hands-on experience with Veeva and other regulatory tools.
• Proven ability to manage global stakeholders and lead teams.

📌 Team Lead – Regulatory Affairs (Colombia)
🏢 Freyr Solutions
📍 Colombia