Product Responsible Person – US Labeling - Colombia

Freyr Solutions; Colombia; Remote; COP 297,138,000 - 495,229,000; Full time

Benefits offered by this job

Flexible remote work environment

Competitive salary and benefits

Professional growth opportunities

Collaborative and inclusive culture

Job summary

Freyr Solutions is seeking a Product Responsible Person for US Labeling (Global Labeling) to lead regulatory labeling efforts remotely. You will act as the regulatory expert in client meetings, manage SPL submissions with internal and external teams, and support packaging artwork development while guiding the Global Supply Chain.

The role requires strong English communication and cross‑functional collaboration across regions.

Qualifications

• M.Pharm or PharmD with 5–8 years of experience in regulatory labeling.
• Strong knowledge of US labeling requirements (USPI, SPL, packaging artwork, labeling lifecycle).
• Experience with drug/device combination products and regulatory information management systems is a plus.
• Excellent English communication skills and the ability to work with global, cross‑functional teams.
• Able to manage multiple products and priorities independently in a fast‑paced environment.

Responsibilities

• Act as the stakeholder‑facing regulatory expert for US product labeling, representing Global Labeling in client meetings and communications.
• Manage submission‑ready labeling files and Structured Product Labeling (SPL) with Freyr labeling operations and external vendors.
• Support development and approval of packaging artwork and mock‑ups, and communicate implementation guidance to Global Supply Chain.
• Coordinate with Device Labeling teams to support drug/device combination products.
• Assess the impact of labeling changes and US regulations on submission plans, timelines, and products on the market.
• Complete labeling assessments in the client’s quality management system and coordinate translation vendors as needed.
• Partner with client labeling leaders to meet US labeling KPIs and guide junior team members.

Skills

US labeling knowledge

Regulatory labeling

Cross-functional collaboration

Multitasking

Education

M.Pharm or PharmD with 5–8 years regulatory labeling experience

Job description

Freyr is a leading global Regulatory Solutions and Services company, supporting large, mid, and small‑size 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.

Job Title: Product Responsible Person – US Labeling (Global Labeling)

Location: Remote

Job Type: Full‑time

Responsibilities

• Act as the stakeholder‑facing regulatory expert for US product labeling, representing Global Labeling in client meetings and communications.
• Manage submission‑ready labeling files and Structured Product Labeling (SPL) with Freyr labeling operations and external vendors.
• Support development and approval of packaging artwork and mock‑ups, and communicate implementation guidance to Global Supply Chain.
• Coordinate with Device Labeling teams to support drug/device combination products.
• Assess the impact of labeling changes and US regulations on submission plans, timelines, and products on the market.
• Complete labeling assessments in the client’s quality management system and coordinate translation vendors as needed.
• Partner with client labeling leaders to meet US labeling KPIs and guide junior team members.

Required Skills

• M.Pharm or PharmD with 5–8 years of experience in regulatory labeling.
• Strong knowledge of US labeling requirements (USPI, SPL, packaging artwork, and labeling lifecycle).
• Experience with drug/device combination products and regulatory information management systems is a plus.
• Excellent English communication skills and the ability to work with global, cross‑functional teams.
• Able to manage multiple products and priorities independently in a fast‑paced environment.

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 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.