Job Description

This role requires 3 days per week in Waltham, MA office.

The Director, U.S. Regulatory Affairs is responsible for developing and executing U.S. regulatory strategies for investigational and marketed drug products, while contributing to integrated global regulatory plans. The role provides regulatory leadership across development programs, directs health authority interactions and submissions, and partners with cross-functional teams to support timely, high-quality decisions throughout the product lifecycle.

Key Responsibilities:

• Develop, communicate, and execute U.S. regulatory strategies that align with clinical development plans, program objectives, and global registration strategy.
• Serve as the primary regulatory lead for assigned programs and provide clear, risk-based advice to clinical, nonclinical, CMC, quality, safety, medical, and commercial stakeholders.
• Lead the planning, preparation, quality review, submission, and follow-up of U.S. regulatory filings, including INDs, CTAs, amendments, annual reports, meeting packages, NDAs, and related lifecycle submissions, as applicable.
• Plan and manage FDA interactions, including meeting requests, briefing packages, rehearsals, meeting conduct, minutes, commitments, and follow-up actions.
• Assess regulatory risks, opportunities, precedents, and emerging requirements; present practical recommendations and escalation options to governance bodies and senior leadership.
• Ensure submission content is accurate, consistent, complete, and delivered in accordance with agreed timelines and applicable requirements.
• Coordinate regulatory deliverables across functions, regions, external partners, and vendors; clarify ownership, dependencies, and decision points.
• Support ex-U.S. and global regulatory strategies and submissions, including collaboration on CTA and ethics committee materials where relevant to assigned programs.
• Maintain current knowledge of FDA regulations, guidance, policies, and relevant international requirements; translate changes into program impact assessments and targeted training.
• Ensure regulatory records, correspondence, commitments, and submission documentation are maintained in approved document management systems and are inspection-ready.
• Contribute to regulatory process improvements, standards, templates, and lessons learned that strengthen quality and operational effectiveness.
• Perform other duties consistent with the scope and level of the position.

Educational Requirements:

• Advanced degree in pharmacy, medicine, life sciences, or a related discipline preferred

Experience:

• 10+ years of experience in regulatory affairs
• Familiarity with regulatory frameworks and technical guidelines of FDA, EMA and other major health authorities, with hands-on experience in communication with regulatory agencies at all levels.
• Language: full professional proficiency in written and spoken English.

Other Skills and Abilities:

• Strong sense of responsibility, excellent communication skills, ability to work independently, and teamwork spirit.

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