Principal Scientist, Regulatory Liaison - Immunology

Scorpion Therapeutics; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for immunology projects, overseeing product registration, labeling, and approval processes.

You will serve as the primary regulatory contact, develop and execute global strategies, coordinate submissions with agencies (FDA, EMA), review dossiers and study protocols, and interact independently with regulators while guiding cross-functional teams through IND/CTA

Qualifications

• B.S./M.S. with 7+ years or PhD/MD with 5+ years in drug development, regulatory affairs or related fields.
• Experience in immunology preferred.
• Regulatory liaison experience with global strategies.

Responsibilities

• Serve as the primary regulatory contact.
• Develop and execute global regulatory strategies.
• Coordinate submissions with agencies (FDA, EMA).
• Review dossiers and study protocols.
• Interact independently with regulators.
• Manage cross-functional teams and support regulatory filings for investigational and marketed biologics.

Skills

Regulatory strategy

Global submissions

Agency interactions

Immunology

Education

B.S./M.S. with 7+ years

PhD/MD with 5+ years

Tools

Dossier management systems

Regulatory submission platforms

Job description

Role

Director (Principal Scientist), Global Regulatory Liaison, leads worldwide regulatory strategies for immunology projects, overseeing product registration, labeling, and approval processes.

Responsibilities

• serve as the primary regulatory contact
• develop and execute global strategies
• coordinate submissions with agencies (FDA, EMA)
• review dossiers and study protocols
• and interact independently with regulators
• Manage cross-functional teams and support regulatory filings for investigational and marketed biologics.

Requirements

B.S./M.S. with 7+ years or PhD/MD with 5+ years in drug development, regulatory affairs, or related fields, with experience in immunology preferred.

High-Value

immunology therapeutics, biologics, regulatory strategy, global submissions, agency interactions, IND/CTA preparations; 10% travel, remote work possible.