Global Regulatory Strategy Director, Immunology

Monte Rosa Therapeutics Inc.; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Monte Rosa Therapeutics Inc. in Boston, MA is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategies for our immunology programs, from development through registration and lifecycle management.

The successful candidate will partner with cross‑functional teams, manage IND/CTA submissions, lead meetings with FDA/EMA, ensure global compliance, and drive strategic regulatory initiatives across programs.

Qualifications

• Minimum 12 years of global regulatory affairs experience in pharma/biotech.
• Experience leading regulatory submissions (INDs/CTAs) for US/EU.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Develop and lead global regulatory strategies from development through approval.
• Prepare and maintain regulatory submissions (INDs, CTAs, filings).
• Lead health authority interactions with FDA, EMA, and others.
• Ensure compliance with FDA, EMA, ICH guidelines.
• Collaborate with stakeholders and oversee vendors.

Skills

Global regulatory strategy

Regulatory submissions

Leadership

FDA/EMA interactions

Education

Bachelor's degree in health sciences or related field

Advanced degree preferred

Job description

Monte Rosa Therapeutics Inc. in Boston, MA is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategies for our immunology programs, from development through registration and lifecycle management.

The successful candidate will partner with cross‑functional teams, manage IND/CTA submissions, lead meetings with FDA/EMA, ensure global compliance, and drive strategic regulatory initiatives across programs.