HW3 is partnered with a reputable pharmacuetical organization to hire a Director/Senior Director, Regulatory Affairs for their Neuro/CNS therapeutic programs.

This is a hybrid position. While the company operates across multiple U.S. and global locations, the role will be primarily remote, with an expectation of spending one week per month on-site at the Massachusetts office.

Overview

The Senior Director, Regulatory Affairs for the Neuroscience therapeutic area will provide strategic leadership for global regulatory activities supporting a portfolio of innovative programs across early development, late-stage clinical programs, and marketed products. This role oversees regulatory strategy, ensures compliance with evolving global regulations, and partners closely with R&D and commercial teams to drive successful product development and approval pathways.

Key Responsibilities

Regulatory Strategy & Leadership

• Develop and lead global regulatory strategies for neuroscience programs across all phases of development, ensuring alignment with corporate priorities and scientific objectives.
• Serve as the primary regulatory point of contact for internal governance boards and cross-functional leadership teams.
• Anticipate and interpret regulatory trends, evolving guidelines, and competitive landscapes affecting the neuroscience portfolio.
• Direct global interactions with global regulatory authorities (e.g., FDA, EMA, PMDA), including leading major submission meetings, scientific advice interactions, and negotiation of regulatory pathways.
• Oversee the preparation, review, and quality of briefing packages, meeting documentation, and formal submissions.

Regulatory Submissions & Documentation

• Provide strategic oversight for the development and maintenance of key regulatory submissions, including INDs/CTAs, meeting packages, Orphan Drug and Breakthrough Therapy designations, and global marketing applications (e.g., NDA/BLA/MAA).
• Ensure regulatory deliverables are scientifically sound, strategically differentiated, and compliant with regional requirements.

Qualifications

• Advanced degree in a scientific or medical discipline (PharmD, PhD, MD, or equivalent preferred).
• Extensive experience (typically 12+ years) in regulatory affairs within the pharmaceutical or biotechnology industry.
• Demonstrated success leading regulatory strategy for CNS or neuroscience programs, including recent hands-on experience with global submissions and interactions with major regulatory agencies.
• Proven experience directing complex development programs and leading cross-functional teams.
• Deep knowledge of global regulatory frameworks, including experience with expedited pathways.