Remote Team Lead, Regulatory Affairs & Lifecycle Management

Freyr Solutions; Colombia; Remote; COP 120,000,000 - 180,000,000; Full time

Benefits offered by this job

Flexible remote work environment

Job summary

Freyr Colombia SAS is seeking a Team Lead – Regulatory Affairs (CMC / Lifecycle Management) to drive global variation strategies, lead a cross-functional team, and oversee regulatory submissions across EU, APAC, Africa, MENA, and LATAM.

The ideal candidate holds a Master’s degree in Pharmacy or Life Sciences, 4–8 years in CMC regulatory affairs, and hands-on experience with Veeva, with a proven ability to coordinate stakeholders and deliver timely outcomes in a fast-paced, inclusive environment.

Qualifications

• 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 regulatory tools.
• Proven ability to manage global stakeholders and lead teams.
• Excellent communication and collaboration skills.

Responsibilities

• Perform and review Change Control impact assessments and define global 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.

Skills

Regulatory leadership

Stakeholder management

Cross-functional collaboration

Communication skills

Team management

Education

Master’s degree in Pharmacy or Life Sciences

Tools

Veeva

Job description

Freyr Colombia SAS is seeking a Team Lead – Regulatory Affairs (CMC / Lifecycle Management) to drive global variation strategies, lead a cross-functional team, and oversee regulatory submissions across EU, APAC, Africa, MENA, and LATAM.

The ideal candidate holds a Master’s degree in Pharmacy or Life Sciences, 4–8 years in CMC regulatory affairs, and hands-on experience with Veeva, with a proven ability to coordinate stakeholders and deliver timely outcomes in a fast-paced, inclusive environment.