Manager Clinical Data
monterosatx
FULL TIME💰 USD 115K–145K/yr
Director, Regulatory Affairs – Global Regulatory Strategy
monterosatx· Regulatory
About this role
Overview
Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. The ideal candidate will be responsible for developing and executing regulatory strategies that support global product development and registration. This role requires 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.
Responsibilities
- Develop and lead global regulatory strategies for assigned programs from early development through approval and lifecycle management.
- 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.
- Responsible for the maintenance of regulatory files and database, tracking regulatory commitments, and supporting the development of processes, SOPs, work instructions, and other controlled documents.
- Additional duties and responsibilities as required.
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.
- Ability to build and maintain effective working relationships with internal and external stakeholders.
Frequently Asked Questions
What is the salary for the Director, Regulatory Affairs – Global Regulatory Strategy role at monterosatx?
The listed salary for this Director, Regulatory Affairs – Global Regulatory Strategy position at monterosatx is USD 180K–245K/yr. This is an FULL TIME role.
Where is the Director, Regulatory Affairs – Global Regulatory Strategy position at monterosatx located?
This Director, Regulatory Affairs – Global Regulatory Strategy role at monterosatx is based in Boston, MA, US. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Director, Regulatory Affairs – Global Regulatory Strategy role at monterosatx full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Director, Regulatory Affairs – Global Regulatory Strategy role in the Regulatory department at monterosatx.
Which team or department does the Director, Regulatory Affairs – Global Regulatory Strategy at monterosatx belong to?
This Director, Regulatory Affairs – Global Regulatory Strategy position is part of the Regulatory department at monterosatx. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Director, Regulatory Affairs – Global Regulatory Strategy position at monterosatx?
Click the "Apply Now" button on this page. You will be redirected to monterosatx's official application portal hosted on icims where you can submit your application directly.
When was the Director, Regulatory Affairs – Global Regulatory Strategy job at monterosatx posted?
This Director, Regulatory Affairs – Global Regulatory Strategy position at monterosatx was posted on Mar 9, 2026. Apply as soon as possible — early applications are often reviewed first.
Director, Regulatory Affairs – Global Regulatory Strategy
monterosatx · 💰 USD 180K–245K/yr
You'll be redirected to monterosatx's official application page on icims.