Director, Global Regulatory Affairs, Neuroscience

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.

Requirements

• BSc Degree, preferred. BA accepted.
• 10+ years of pharmaceutical industry experience.
• 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience.
• Solid working knowledge of drug development process and regulatory requirements.
• Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Must work well with others and within global teams.
• Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally;

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time
• Up to 120 hours of paid vacation