Associate Director, Global Labeling Strategy (Remote)

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling for rare disease therapies across the product lifecycle. You will chair the Labeling Working Group, coordinate with Health Authorities, and author critical labeling documents (USPI, CCDS, TPL) while shaping global implementation plans.

The role requires 8+ years in pharma/biotech with extensive labeling/regulatory experience, deep US/EU knowledge, and interaction across Clinical, Medical,

Qualifications

• Bachelor's degree in a scientific discipline.
• 8+ years in pharma/biotech with 6+ years in labeling or regulatory roles.
• Deep knowledge of US and EU labeling requirements and guidelines.
• Experience with global regulatory submissions (INDs, BLAs/NDA, MAAs).

Responsibilities

• Lead cross-functional Labeling Working Group.
• Coordinate with Health Authorities.
• Author and manage labeling documents (USPI, CCDS, TPL).
• Develop global labeling implementation plans.
• Oversee label negotiations and approvals.
• Advise on labeling implications across development and post-marketing, ensuring compliance; drive process improvements.

Skills

Labeling regulations

Regulatory submissions

Cross-functional collaboration

Pharma/biotech experience

Education

Bachelor's degree in science

Tools

INDs

BLAs/NDA

MAAs

Structured labels

Job description

Scorpion Therapeutics is seeking an Associate Director, Labeling Strategy to lead global regulatory labeling for rare disease therapies across the product lifecycle. You will chair the Labeling Working Group, coordinate with Health Authorities, and author critical labeling documents (USPI, CCDS, TPL) while shaping global implementation plans.

The role requires 8+ years in pharma/biotech with extensive labeling/regulatory experience, deep US/EU knowledge, and interaction across Clinical, Medical,