Associate Director, Regulatory Affairs Project Management

Responsibilities

• Lead submission planning discussions with the Regulatory team
• Create and maintain a Global Submission Plan detailing dossier content and timelines
• Cook up and manage post-initial submission activities for the approval process
• Manage submission documents and components for simultaneous global projects
• Track and ensure timely delivery of submission components
• Advises on global Regulatory Authority regulations for electronic submissions
• Utilize project management skills to oversee multiple projects effectively

Qualifications

• Bachelor's Degree in life sciences or chemistry preferred
• 7+ years of regulatory affairs experience
• Project management experience in the pharmaceutical industry
• Regulatory experience from pre-IND through Phases I-IV for FDA, EMA, MHRA, and PMDA
• Proficiency in Veeva Vault RIM, Smartsheet, and Microsoft Office
• Excellent communication and organizational skills
• Ability to lead cross-functional teams in a matrix environment

Benefits

• Comprehensive medical, dental, and vision coverage
• Generous paid time off policies and flexible work schedules
• 401(k) plan with competitive company match
• Access to company Learning Institute for professional development
• Participation in Employee Stock Purchase Plan and annual equity awards