Global Labelling Lead

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• The Global Labeling Lead (GLL) acts as a specialist in labeling strategy for Sobi products within Global Regulatory Affairs (GRA).

• The GLL offers both strategic and operational direction for product labeling, collaborating closely with Regulatory Strategy Leads and various cross-functional stakeholders.

• Ensure adherence to applicable Health Authority (HA) regulations, internal protocols, and corporate objectives.

• Facilitate the ongoing enhancement of labeling processes and systems.

• Lead the creation, execution, and upkeep of the CCDS, USPI, and EU PI for designated Sobi products throughout their lifecycle via cross-functional Labeling Working Groups (LWG).

• Record and store LWG decisions and outcomes.

• Collaborate with international Regulatory Affairs (RA) to oversee the review and approval of labels intended for submission outside of the EU and US.

• Maintain oversight of labeling compliance, which includes documenting deviations in labeling content and tracking safety variations from start to finish.

⛳️ Requirements

• Degree (Bachelors, Masters, State Examination, Diploma), ideally in a scientific field such as Pharmacy, Medicine, Life Sciences, or Natural Sciences.

• A minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical sector or a regulatory body, including at least 3 years of pertinent experience in prescription drug labeling.

• Familiarity with various types of labeling documents, such as (Development) Core Data Sheets, EU and/or US Prescribing Information, and Target Product Labels, for both marketed and investigational products.

• Experience in leading project teams within a cross-functional matrix environment.

• Comfortable operating in a global, cross-functional setting, effectively collaborating with stakeholders across diverse regions, time zones, and cultural backgrounds.

• Experience utilizing Regulatory Information Management systems.

• Strong command of standard business tools (e.g., MS-Office, etc.).

• Excellent English language proficiency (oral/written/listening); knowledge of additional languages is a plus.

• Capability to plan, coordinate, and manage multiple projects simultaneously.

🏝️ Benefits

• Competitive compensation for your contributions.

• Focus on work/life balance.

• Collaborative and team-oriented atmosphere.

• Opportunities for professional development.

• Commitment to Diversity and Inclusion.

• Contributing to a positive impact for ultra-rare disease patients in need of life-saving treatments.