Associate Director, Regulatory Labeling Strategy

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

Role

Associate Director, Labeling Strategy, responsible for developing and executing global regulatory labeling strategies throughout the product lifecycle for rare disease therapies.

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 approval processes
• Provide strategic guidance on labeling implications for development and post-marketing activities, ensuring compliance with US and EU regulations, and lead continuous process improvements

Requirements

• Bachelor's degree in a scientific discipline
• 8+ years in pharmaceutical/biotech industry with at least 6 years in labeling or regulatory roles
• Deep knowledge of US and EU labeling requirements, regulations, and guidelines
• Experience with global regulatory submissions, including INDs, BLAs/NDA, MAAs, and structured product labels

High Value

Rare disease focus, global regulatory environment, experience with USPI and EU SmPC, involvement in development and post-marketing stages, and cross-functional collaboration with Clinical, Medical, Regulatory, and Quality teams.

Work Setup

Remote in San Diego, with approximately 10% domestic and international travel.