Director of Regulatory Affairs

Job Summary

A company is looking for a Director, Regulatory Affairs.

Key Responsibilities

• Develop and direct innovative regulatory strategies for assigned portfolio projects
• Provide regulatory guidance on clinical development plans and oversee regulatory document submissions
• Monitor regulatory landscape changes and collaborate with external partners and regulatory agencies

Required Qualifications

• Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field preferred
• Minimum of 10 years of regulatory affairs experience in biotechnology or pharmaceutical industry
• Experience in regulatory strategy for neuroscience or CNS therapeutics is highly preferred
• Demonstrated success leading regulatory submissions and interactions with global health authorities
• Strong understanding of global regulatory frameworks (e.g., FDA, EMA, ICH)