Global Labeling Lead

Job Overview

Global Labeling Lead – Sobi, Boston, MA, US (remote, primarily East Coast).
Key Focus: Serve as a labeling strategy expert for Sobi products within Global Regulatory Affairs.

At Sobi, we develop and deliver innovative therapies for rare diseases. We value teamwork, patient focus, and a culture of collaboration and impact.

• Lead content development, approval, and maintenance of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI).
• Manage review and approval of country labeling for new filings in international markets.
• Ensure compliance with Health Authority regulations, internal procedures, and business objectives.
• Support continuous improvement of labeling processes and systems.
• Guide labeling working groups (LWGs) in discussions with Health Authorities, ensuring governance and alignment.
• Present new labeling content and major updates to the Executive Labeling Committee.
• Partner with international Regulatory Affairs to guide label review and approval for non‑EU/US markets.
• Maintain oversight of labeling compliance, track deviations, and ensure end‑to‑end tracking of safety variations.
• Contribute to process improvement, including creation and review of process documents.
• Support inspections and audits related to labeling activities.
• Participate in cross‑functional initiatives to strengthen collaboration and operational efficiencies.

• Education: Bachelor’s, Master’s, state examination or diploma in Pharmacy, Medicine, Life or Natural Sciences.
• Experience: Minimum 5 years in Regulatory Affairs within the pharmaceutical industry or regulatory authority, with at least 3 years in US prescription drug labeling.
• Ability to work globally, across multiple regions, time zones, and cultures.

• Experience with Core Data Sheets, Prescribing Information, and Target Product Labels for marketed and investigational products.
• Knowledge of labeling requirements outside the US, preferably Europe and/or Japan.
• Leadership experience in a cross‑functional matrix environment.

• Experience with Regulatory Information Management systems.
• Proficiency with standard business tools (MS‑Office).
• Excellent English (oral, written, listening); additional languages are an advantage.
• Strong project planning, coordination, and leadership across multiple projects.
• Self‑motivated, reliable, decisive, and team‑oriented.
• Strong communication and presentation skills at all levels.
• Curiosity, proactive learning, and continuous improvement mindset.

• Base salary range: $155,000 – $190,000.
• Short‑term and long‑term bonuses.
• Competitive 401(k) match.
• Tuition and wellness reimbursements.
• Comprehensive medical, dental, and vision package.
• Additional recognition awards.
• Generous time‑off policy and emphasis on work/life balance.

Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to protected characteristics.

Qualified individuals with a disability or disabled veteran may request a reasonable accommodation by emailing .

Interested candidates should submit a resume and cover letter through our application portal. We look forward to your application!