Director, Regulatory Affairs – Global Regulatory Strategy

Role Summary

Director of Regulatory Affairs – Global Regulatory Strategy based in Boston, MA, leads and supports global regulatory efforts across development programs with a focus on immunology. Responsible for developing and executing regulatory strategies to support global product development and registration. This role requires strong regulatory knowledge, leadership, and the ability to work effectively in a cross-functional environment. Global regulatory experience is required, with immunology background preferred and CMC experience 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

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