Senior Director, Global Regulatory Lead

We are seeking a Senior Director, Global Regulatory Lead to develop and execute regulatory strategies for assigned assets, ensuring compliance with internal processes and regulatory requirements. This role will lead regulatory interactions and review processes, and advocate for senior leaders and Health Authorities.

Requirements

• Bachelor’s degree in life sciences, pharmacy, medicine or a related discipline
• Extensive experience (7+ years) of all phases of the drug development process in regulatory affairs
• Proven track record of leading development, submission and approval activities
• Extensive knowledge of clinical trial and licensing requirements in priority markets and sound knowledge globally
• Advanced degree (Master’s, PharmD, MD or PhD) in a life science or related field (preferred)
• Deep knowledge of clinical development, CMC and regulatory requirements across major markets (preferred)
• Track record of successful global submissions and positive interactions with multiple regulatory agencies (preferred)
• Previous line management responsibilities (preferred)
• Experience building or scaling regulatory teams and developing talent (preferred)

Benefits

• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Paid caregiver/parental and medical leave