Freelance Regulatory Submissions Specialist | Job ID: Job #2159

Location:

Senior Regulatory Operations Specialist (Pharma/Health)

Ensure regulatory compliance for our Princeton-based pharmaceutical/health clients!

We seek a detail-oriented pro to manage regulatory submissions. You'll be the go-to for client MLR (Medical, Legal & Regulatory) processes and tools.

Responsibilities:

  • Manage submission workflow and become an expert on client MLR systems.
  • Oversee project flow, ensuring timely and accurate submissions.
  • Lead the submission team, filtering workload and maintaining project trackers.
  • Collaborate with Project Management to meet deadlines and client requirements.
  • Maintain reference libraries and ensure submission materials meet MLR standards.
  • Track project progress, provide status updates, and submit materials electronically.
  • Document client MLR requirements and maintain regulatory document control.

Qualifications:

  • 5+ years' experience (regulatory affairs, project management a plus).
  • Strong interpersonal and problem-solving skills.
  • Excellent written and verbal communication.
  • Highly organized and detail-oriented.
  • Proficient in MS Office, Veeva Vault, and similar electronic systems.

Benefits:

  • Competitive salary and benefits package.
  • Fast-paced, growing environment.
  • Collaborative and supportive work culture.

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