Associate Specialist - Regulatory Affairs (Hybrid) Job at Merck, Ludlow, PA

  • Merck
  • Ludlow, PA

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

Job Tags

Work at office

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