Principal Scientist, Regulatory Liaison - Immunology

Merck; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics is seeking a Lead Global Regulatory Strategist for Immunology programs to shape worldwide regulatory pathways and accelerate approvals. You will drive submissions, interact with FDA/EMA, and align cross-functional teams across development and lifecycle stages.

The role requires extensive regulatory expertise in immunology, biologics or small molecules, and a proven track record in global filings and agency interactions. Remote work with travel up to 10% is expected.

Qualifications

• 7+ years in drug development with regulatory experience.
• Immunology regulatory experience is required.
• Global filings and agency interactions demonstrated.
• Strong communication and strategic thinking are essential.

Responsibilities

• Serve as single point of contact for products across development and lifecycle.
• Coordinate regulatory submissions and agency interactions (FDA/EMA).
• Review regulatory documents including marketing applications, clinical reports, and protocols.
• Guide cross-functional teams on regulatory strategy.

Skills

Regulatory strategy

Global filings

Agency interactions

Communication

Strategic thinking

Education

Bachelor's or Master's in life sciences

PhD/MD/PharmD in related field

Job description

Role

Lead global regulatory strategist for Immunology projects, responsible for developing and implementing worldwide regulatory pathways to optimize labeling and accelerate approvals.

Responsibilities

act as the single point of contact for assigned products across development and lifecycle stages; coordinate submissions, interactions with agencies (FDA, EMA), and regional teams; review regulatory documents including marketing applications, clinical reports, and protocols; and guide cross-functional teams on regulatory strategy.

Requirements

B.S./M.S. with 7+ years or PhD/MD/PharmD with 5+ years in drug development, with strong regulatory experience, especially in immunology; proven expertise in global filings and agency interactions; excellent communication and strategic thinking skills.

HighValue:

immunology, biologics or small molecules, global regulatory strategy, IND/CTA preparation, experience with FDA and EMA.

WorkSetup:

remote with 10% travel.