Associate Director, Regulatory

University of Pennsylvania

Philadelphia, Pennsylvania, US
Base: $105,500.00 - $130,000.00 annual rate; bonus...
Hybrid
Clinical research regulatory oversight
Gcp and fda cfr knowledge
Regulatory submission mechanisms
The Associate Director will oversee the portfolio of clinical research and provide strategic planning for regulatory operations within the department

Job Summary

  • The Associate Director will oversee the portfolio of clinical research and provide strategic planning for regulatory operations within the department.
  • Candidates must possess expert knowledge of GCP, Title 21 CFR, and ICH guidelines along with required ACRP or RAC certification.
  • The University offers a competitive benefits package including excellent healthcare, tuition benefits, and generous retirement plans.

Matching Summary

The Associate Director will oversee the portfolio of clinical research and provide strategic planning for regulatory operations within the department.

Salary

Base: $105,500.00 - $130,000.00 Annual Rate; Bonus/Equity: Not specified; Benefits: Comprehensive healthcare, tuition assistance, retirement plans

Skills & Requirements

Must-have

  • Clinical research regulatory oversight
  • GCP and FDA CFR knowledge
  • Regulatory submission mechanisms
  • IND/IDE application experience
  • Staff training and mentorship
  • Audit preparation and resolution

Nice-to-have

  • Veeva Systems or eFlorence experience
  • Strong analytical and critical thinking
  • Collaborative cross-departmental leadership
  • Fast-paced environment adaptability
  • Openness to constructive criticism

Key Requirements

  • Bachelor's degree with 7-10 years relevant experience
  • Master's degree preferred
  • ACRP and/or RAC certification required
  • Expert knowledge of IND/IDE applications
  • Experience with FDA submission portals

Work Rights

Not specified

Tailored Resume

Cover Letter