Job Summary

• The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio.
• Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks.
• Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.

Matching Summary

Salary

Base: $177,000.00 - $278,080.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision insurance, 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, sick time, paid vacation

Skills & Requirements

Key Requirements

• BSc Degree or BA accepted
• 10+ years pharmaceutical industry experience
• 6 years regulatory experience or combination
• Reviewing, authoring, or managing submissions
• Solid working knowledge of drug development process
• Knowledge of FDA, EU, Canada, ROW
• Strong oral and written communications

Work Rights