Global Labeling Strategist - Regulatory Affairs (Remote)

Amgen Inc. (IR); Northern (KY); Hybrid; USD 133,000 - 180,000; Full time

Job summary

Amgen Inc. is seeking a Labeling Strategist to lead global labeling operations, driving end‑to‑end labeling processes through product lifecycles. You will shape core documents like CDS, cPIL, and US labeling, while coordinating regional labeling deliverables and health authority interactions.

You will guide regulatory teams, contribute to strategic labeling decisions, and supervise labeling specialists, with ~10% travel. Strong regulatory, medical, and project management skills are essential.

Qualifications

• Advanced knowledge of global labeling regulatory requirements and processes.
• Experience leading labeling projects across regions with strategic impact.
• Strong writing and editing skills for high‑quality core labeling documents.

Responsibilities

• Chairs and leads labeling working groups and cross‑functional meetings.
• Develops and maintains core labeling documents (CDS, cPIL, cIFU) and regional labeling (USPI, PPI).
• Provides strategic labeling guidance for major regions and aligns with global labeling plans.

Skills

Regulatory strategy

Labeling knowledge

Cross-functional collaboration

Technical writing

Project management

Communication skills

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva

Documentum

Job description

Amgen Inc. is seeking a Labeling Strategist to lead global labeling operations, driving end‑to‑end labeling processes through product lifecycles. You will shape core documents like CDS, cPIL, and US labeling, while coordinating regional labeling deliverables and health authority interactions.

You will guide regulatory teams, contribute to strategic labeling decisions, and supervise labeling specialists, with ~10% travel. Strong regulatory, medical, and project management skills are essential.