Principal Scientist, Regulatory Liaison - Immunology

About the role

The Principal Scientist, Global Regulatory Liaison will lead worldwide regulatory strategies for immunology products, acting as the single point of contact for regulatory agencies and internal teams.

Key responsibilities

• Develop and implement global regulatory strategies to optimize labeling and accelerate approvals.
• Lead interactions with agencies such as FDA and EMA, including meetings, teleconferences, and written communications.
• Coordinate preparation, submission, and follow‑up of regulatory applications across regions.
• Provide expert regulatory advice to product development teams throughout the product lifecycle.

Required profile

• Minimum B.S./M.S. with 7 years of drug development experience (or M.D./PhD/PharmD with 5 years, including 3 years in regulatory affairs).
• Strong strategic thinking, problem‑solving, and communication skills.
• Experience leading regulatory filings in major markets (U.S., EU, Japan, China).
• Therapeutic area expertise in immunology is preferred.

Required skills

• Global regulatory affairs management
• Drug development processes
• IND/CTA preparation
• Regulatory submissions to FDA, EMA and other agencies

What we offer

• Salary range $173,200 – $272,600 per year, with annual bonus and long‑term incentives.
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays, vacation, and sick days.