Global Regulatory Strategy Director – Immunology

Monte Rosa Therapeutics, Inc; Boston (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology.

The successful candidate will have at least 12 years of experience in global regulatory affairs, strong leadership skills, and the ability to manage regulatory submissions and work with health authorities such as the FDA and EMA.

Qualifications

• Minimum of 12 years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry.
• Demonstrated experience leading health authority meetings, including with the FDA, EMA, PMDA.
• Experience in immunology or cardiovascular therapeutic area preferred.

Responsibilities

• Develop and lead global regulatory strategies for assigned programs.
• Lead the preparation and submission of regulatory applications.
• Ensure compliance with global regulatory requirements.

Skills

Global regulatory strategy experience

Leadership skills

Strong understanding of regulatory requirements

Ability to build relationships with stakeholders

Education

Bachelor's degree in health sciences or related field

Advanced degree preferred

Job description

Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology.

The successful candidate will have at least 12 years of experience in global regulatory affairs, strong leadership skills, and the ability to manage regulatory submissions and work with health authorities such as the FDA and EMA.