EU Labeling Scientist

About the role

We are seeking an EU Labeling Scientist to join our Global Labeling team. The role supports the development and maintenance of EU product information for marketed pharmaceutical products, ensuring compliance with EU regulations and providing safe, effective labeling for patients and healthcare providers worldwide.

Key responsibilities

• Develop and maintain EU product information and annexes for products registered under EU procedures (MRP/DCP/CP).
• Provide labeling expertise, precedence analysis, and competitor labeling insights to cross‑functional teams.
• Lead and facilitate senior‑level cross‑functional teams to create, review, and approve EU labeling documents.
• Collaborate with data owners and subject‑matter experts to incorporate scientific and medical information.
• Recommend labeling language and strategies during development or regulatory response activities.
• Assess labeling risks, devise mitigation plans, and escalate issues as needed.

Required profile

• Bachelor’s degree in a scientific or medical discipline (advanced degree preferred).
• Minimum of 2 years of labeling or related regulated‑industry experience (e.g., Regulatory Affairs, Medical Writing, Pharmacovigilance).
• Excellent written English communication skills.
• Strong project‑management abilities with capacity to handle multiple priorities.
• Proactive, detail‑oriented, and comfortable working in ambiguous environments.

Required skills

• Medical Writing
• Pharmaceutical Regulatory Affairs
• Regulatory Labeling
• Project Management
• Data Quality Assurance
• Policy Implementation
• Regulatory Communications