Job Description

Associate Specialist supporting regulatory submissions and planning at a pharmaceutical company. The role involves managing FDA documentation, tracking deliverables, and coordinating with cross-functional teams in a hybrid Philadelphia office setting.

Responsibilities

• Support creation of FDA cover letters, forms, and submission plans
• Track timelines and deliverables for regulatory submission components
• Manage regulatory documents and maintain accountability for tracking systems
• Collaborate with colleagues across departments to coordinate regulatory activities
• Participate in process improvements and training to build regulatory expertise

Requirements

• High school diploma or equivalent
• Strong verbal and written communication across organizational levels
• Proficiency with Microsoft Office; advanced Excel and Word skills preferred
• Demonstrated problem-solving ability and independent work capability
• Highly organized with meticulous attention to detail
• Experience with document control systems and regulatory processes desired

Compensation: $71,900–$113,200 base

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