US Labeling Regulatory Lead – Remote

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 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.