Global Labeling Regulatory Director

Scorpion Therapeutics; Summit (NJ); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Medical benefits

Dental/Vision coverage

401(k) match

PTO/holidays

EAP

Job summary

Scorpion Therapeutics seeks a Director, Global Labeling Regulatory to steer global labeling strategy from early clinical through commercialization. You will lead a cross-functional team, ensure USPI/EU SmPC alignment, and supervise labeling content with manufacturing and vendors.

The role requires extensive health authority regulatory labeling experience, and expertise in eCTD/CMC matters, with oversight of labeling change controls and SOP training.

Qualifications

• Extensive global health authority regulatory labeling experience.
• Experience with USPI and EU SmPC labeling.
• Strong leadership and project management skills.

Responsibilities

• Lead creation and execution of global labeling strategies from clinical to commercialization.
• Directly manage labeling team, coaching and performance reviews.
• Prepare and maintain key labeling documents (USPI, EU SmPC).
• Ensure compliance with health authority regs and GMP across labeling.
• Oversee label content updates with manufacturing and vendors.
• Review/approve label proofs from internal/external teams.
• Draft responses to health authority questions on labeling.
• Collaborate on global labeling/CMC matters and change controls.
• Oversee label specifications and training on Regulatory Affairs SOPs.

Skills

Global labeling strategy leadership

Team leadership and coaching

Regulatory labeling compliance

Cross-functional collaboration

Education

Bachelor’s degree in life sciences or related field

Master’s degree (preferred) in life sciences/technical field

Tools

Veeva Vault

Job description

Scorpion Therapeutics seeks a Director, Global Labeling Regulatory to steer global labeling strategy from early clinical through commercialization. You will lead a cross-functional team, ensure USPI/EU SmPC alignment, and supervise labeling content with manufacturing and vendors.

The role requires extensive health authority regulatory labeling experience, and expertise in eCTD/CMC matters, with oversight of labeling change controls and SOP training.