About the Opportunity

An innovative neuropsychology company is seeking an experienced and strategic regulatory leader to join a growing biotechnology organization advancing innovative therapies for patients with significant unmet medical needs. This individual will play a key role in shaping regulatory strategy, guiding health authority interactions, and partnering with cross-functional teams to support clinical development programs.

This is an exciting opportunity for a hands-on leader who thrives in a collaborative, fast-paced environment and is passionate about bringing new therapies to patients.

What You’ll Do

• Lead the development and execution of global regulatory strategies across clinical-stage programs.
• Serve as a key regulatory representative in interactions with health authorities and external stakeholders.
• Provide strategic regulatory guidance on development plans, submission strategies, and regulatory pathways.
• Oversee the preparation, review, and submission of regulatory documents supporting clinical development activities.
• Partner closely with Clinical Development, CMC, Nonclinical, Quality, and other cross-functional teams to ensure alignment and successful execution.
• Monitor emerging regulatory trends and assess potential impacts on development programs.
• Support business development initiatives, due diligence efforts, and other strategic projects as needed.
• Help build and strengthen regulatory processes, capabilities, and best practices within the organization.

What We’re Looking For

• Advanced degree in a scientific, healthcare, or related discipline preferred.
• Significant experience in Regulatory Affairs, Regulatory Science, or a related function within the biotechnology or pharmaceutical industry.
• Demonstrated experience developing regulatory strategy and engaging with global health authorities.
• Strong understanding of drug development and regulatory frameworks.
• Proven ability to influence cross-functional teams and drive complex initiatives forward.
• Excellent communication, leadership, and problem-solving skills.
• Comfortable working in a dynamic, entrepreneurial environment where flexibility and collaboration are critical to success.

Why Join Us?

• Opportunity to make a meaningful impact on innovative therapeutic programs.
• Collaborative, science-driven culture.
• Visibility and partnership with senior leadership.
• Competitive compensation, benefits, and career growth opportunities.