Associate Director, Project Manager - Regulatory Affairs

📋 Description

• Lead regulatory project management activities across one or more global development programs
• Partner with Regulatory Leads to coordinate global regulatory team meetings, including agendas
• Develop and maintain integrated regulatory project plans and timelines covering health authority
• Plan and track major regulatory submissions and maintenance activities, including INDs, NDAs, BLAs
• Coordinate with Regulatory Operations, Clinical Development, Clinical Operations, CMC
• Support submission readiness by coordinating content plans, document ownership, review cycles

🎯 Requirements

• Bachelor’s degree in Life Sciences or a related discipline is required; a Master’s degree, PharmD
• 8+ years of project management experience within the biotechnology or pharmaceutical industry, with
• Strong understanding of global regulatory affairs, submission requirements, compliance processes
• Proven experience creating and managing complex project plans, integrated timelines, critical
• Demonstrated expertise with timeline and project management tools such as Smartsheet or Microsoft
• PMP certification is strongly preferred.

🎁 Benefits

• Target base salary range of $150,000–$195,000 USD, with actual compensation determined by
• Short-term incentive compensation and long-term incentive opportunities through company equity.
• Comprehensive health, financial, work-life, and well-being benefits for eligible employees and
• Medical and wellness programs, employee support resources, life insurance, and disability coverage.
• Retirement plans with employer contributions/match.
• Generous paid time off.