Director, Regulatory Affairs – Global Regulatory Strategy

About the role

The Director of Regulatory Affairs will lead and support global regulatory efforts across Monte Rosa Therapeutics' development programs, with a focus on immunology.

Responsibilities

• Develop and execute regulatory strategies that support global product development and registration.
• Ensure regulatory strategies align with corporate goals and evolving regulatory expectations.
• Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
• Lead regulatory interactions and meetings with global health authorities, including FDA, EMA, and other major agencies.
• Ensure compliance with global regulatory requirements and guidelines, including FDA, EMA, and other regulatory authorities.
• Represent Regulatory on cross-functional product team and provide strategic regulatory guidance and support to achieve product development objectives.
• Collaborate with internal and external stakeholders, manage and oversee third-party vendors and consultants to ensure high-quality submissions, and successful execution of regulatory strategies.
• Maintain regulatory files and database, track regulatory commitments, and support the development of processes, SOPs, work instructions, and other controlled documents.

Requirements

• Strong regulatory knowledge, leadership skills, and the ability to work effectively in a cross-functional environment.
• Global regulatory experience is required, and immunology background is preferred.
• CMC experience is a plus.

Qualifications

• Bachelor's degree in health sciences or related field, or an advanced degree is preferred.
• Minimum of 12 years of experience in global regulatory affairs within the pharmaceutical or biotechnology industry.
• Global regulatory strategy experience is required, including direct involvement with US, EU and international regulatory submissions and strategy.
• Demonstrated experience leading health authority meetings, including with the FDA, EMA, PMDA.
• Strong understanding of regulatory requirements and industry guidelines (FDA, EMA, ICH, etc.).
• Experience in immunology or cardiovascular therapeutic area is preferred.
• CMC regulatory experience or strong working knowledge is a plus.

Skills

• Ability to build and maintain effective working relationships with internal and external stakeholders.

Benefits

N/A

Pay

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Schedule

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