Team Lead – Regulatory Affairs (CMC / 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 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)

Job Type: Full-time Employee

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.

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.
• Excellent communication and collaboration skills.

Why Join Freyr?

• Be part of a global, fast-growing organization with opportunities to work with teams across different regions.
• Work in a dynamic, collaborative, and inclusive environment.
• Competitive salary and benefits package.
• Flexible remote work environment.
• Opportunities for professional growth, learning, and development.
• Collaborate with experienced professionals across the global Life Sciences industry.
• Employee-focused culture that values innovation, integrity, and collaboration.
• Opportunities to build a long-term career within a growing organization.

What We Offer

• Competitive compensation and benefits.
• Flexible remote work environment.
• Professional growth and development opportunities.
• Collaborative and inclusive workplace culture.
• Learning and development opportunities to support your career growth.

Freyr Colombia SAS is an Equal Employment Opportunity Employer. We are committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by applicable law.

We value diversity and inclusion and believe that a diverse workforce strengthens our organization and the communities we serve.

Accessibility

Freyr is committed to providing a workplace that is accessible and inclusive. Reasonable accommodations are available to qualified individuals with disabilities throughout the recruitment and employment process.