Senior Manager, Regulatory Affairs Project Management - Remote

Overview

We are seeking an experienced biotech project manager to optimize planning, execution, and tracking of development-stage global regulatory activities.

In Short

• Key member supporting regulatory activities for clinical trials.
• Drive global submission planning and coordination.
• Blend regulatory expertise with advanced project management skills.
• Monitor timelines and deliverables for regulatory submissions.
• Support strategic planning and risk mitigation efforts.
• Facilitate cross-functional meetings for submission activities.
• Design and maintain Smartsheet tools for regulatory activities.
• Proactive problem-solving in a dynamic environment.
• Collaborate with project and program managers.
• Position requires up to 20% travel.

Requirements

• Bachelor’s degree in life sciences or related field.
• 5+ years of experience in the pharmaceutical or biotech industry.
• Experience with IND/CTA regulatory submissions.
• Familiarity with BLA/NDA/MAA submissions.
• Hands-on Smartsheet experience required.
• Knowledge of biotech processes and drug development concepts.
• Strong organizational and communication skills.
• Ability to manage multiple priorities and meet deadlines.
• Team player with a proactive approach.
• Experience supporting global interventional clinical studies.

Benefits

• Great culture based on C.O.R.E. values.
• Market competitive compensation and benefits package.
• Three weeks PTO and dedicated paid sick leave.
• Commitment to professional growth and development.
• Regular team meetings to build relationships.