Senior Director, Global Regulatory Affairs, Neurology

Location: Hybrid in Nutley, New Jersey, three days per week on Tuesday, Wednesday, and Thursday; remote candidates may be considered if they cannot regularly work in the Nutley office. Regular business travel is required.

Annual base salary: $249,100–$327,000.

Company

Pharmaceutical company focused on research and development in neurology and oncology and on addressing unmet healthcare needs.

What you will do

• Lead global or regional regulatory strategies for assigned neurology or oncology portfolios.
• Oversee regulatory submissions and review documents for quality, compliance, and timelines.
• Lead discussions and prepare complex documents for FDA, EMEA, PMDA, and other health authorities.
• Manage regulatory program budgets, forecasts, vendors, timelines, and resource planning.
• Identify regulatory opportunities and risks and drive process and system improvements.
• Set goals, manage performance, develop employees, and lead regulatory teams.

Requirements

• Bachelor’s degree in science or a related field; a master’s degree is preferred.
• 12+ years of relevant regulatory or R&D experience in the pharmaceutical or biotech industry.
• Experience developing regulatory strategies and managing cross-functional regulatory processes and budgets.
• Strong experience working with FDA laws, regulations, guidances, and international regulations.
• Experience with clinical trials, regulatory submissions, and major NDA, BLA, MAA, or J-NDA submissions is preferred.
• Ability to work in the Nutley, New Jersey hybrid schedule or be considered for remote work if regular office attendance is not possible; regular business travel is required.

Culture & Benefits

• Participation in the hirify.global annual incentive plan and long-term incentive plan.
• Eligibility for company employee benefit programs.
• Equal opportunity employment and reasonable accommodation support.
• Opportunities to influence organizational decisions and collaborate with internal and external committees.