Manager, Regulatory Affairs

Scorpion Therapeutics; United States; Remote; USD 125,000 - 180,000; Full time

Job summary

Scorpion Therapeutics seeks a Manager of Regulatory Affairs to lead global regulatory submissions for investigational and marketed biologics, with a focus on cell therapy. The role covers INDs, BLAs, amendments, and submission strategies, with emphasis on ICH compliance and cross-functional teamwork.

The position requires 8+ years in regulatory affairs, a BA/BS, and hands-on eCTD experience, with remote work to support global programs.

Qualifications

• BA/BS required.
• 8+ years in regulatory affairs or related drug/biologic development.
• Experience with global electronic submissions (eCTD).
• Regulatory agency interactions.
• Regulatory strategy development.

Responsibilities

• Manage INDs and BLAs.
• Handle amendments and prepare documentation.
• Maintain regulatory dossiers.
• Coordinate cross-functionally.
• Ensure compliance with international regulations (ICH).
• Develop submission strategies.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

International regulatory compliance

Documentation management

Education

BA/BS

Advanced degree (preferred)

Tools

eCTD experience

Job description

Role

Manager, Regulatory Affairs, supports global regulatory submissions for investigational and marketed biologics, primarily in cell therapy.

Responsibilities

• managing INDs
• BLAs
• amendments
• preparing documentation
• maintaining regulatory dossiers
• cross-functional collaboration
• ensuring compliance with international regulations like ICH
• developing submission strategies

Requirements

• BA/BS
• 8+ years in regulatory affairs or related drug/biologic development
• experience with global electronic submissions (eCTD)
• regulatory agency interactions
• regulatory strategy development

Preferred

• advanced degree

High-Value

• biologics
• cell therapy
• regulatory submissions for INDs/BLAs
• international regulatory knowledge
• GxP
• document management expertise

Work setup

remote; physical and mental demands consistent with office work.