Global Labeling Lead - Remote

Overview

The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA), providing strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads and other stakeholders.

In Short

• Lead the development and maintenance of the Core Data Sheet (CDS), US PI, and EU SmPC.
• Ensure compliance with Health Authority regulations and internal procedures.
• Manage the review of country labeling deviations.
• Collaborate with internal and partner companies on labeling discussions.
• Document outcomes of labeling meetings and present to executive committees.
• Support the development of Standard Operating Procedures (SOPs).
• Build cross-functional relationships.
• Provide support during inspections and audits.
• Track labeling projects through defined procedures.
• Emphasize work/life balance and team-oriented environment.

Requirements

• Bachelor's or higher degree in a scientific field.
• 8+ years in the pharmaceutical industry or regulatory authority.
• 5+ years in Regulatory Affairs with CDS and EU/US labeling experience.
• Experience in a global cross-functional environment.
• Excellent communication skills in English.
• Proven ability to manage multiple projects simultaneously.
• Detail-oriented and self-motivated.
• Ability to influence outcomes and build relationships.
• Proficiency with technology tools (e.g. MS-Office).
• Knowledge of Regulatory Information Management systems.

Benefits

• Competitive compensation.
• Generous time off policy.
• Summer Fridays.
• Opportunity to attend popular conferences.
• Medical, dental, and vision benefits.
• 401k match and incentives.
• Health and wellness programs.
• Collaborative work environment.
• Focus on making a positive impact for patients.
• Commitment to employee development and empowerment.