Remote Senior Regulatory Affairs Director

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Tue, Oct 13, 2020

This job expires in 15 days

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors, Masters

Job Summary

A ophthalmic medical technology company has a current position open for a Remote Senior Regulatory Affairs Director.

Core Responsibilities of this position include:

  • Providing guidance to inter-disciplinary project teams on regulatory requirements on projects at Phase 1 to IV
  • Generating formal written regulatory strategy documents, primarily for combination drug-device products
  • Interacting and coordinating with Clinical staff to facilitate clinical studies regulatory compliance

Must meet the following requirements for consideration:

  • A Bachelor’s Degree in a scientific discipline from an accredited university is required
  • A minimum of 7 years’ experience in pharmaceuticals
  • 4-5 years’ experience in regulatory supporting development projects
  • Demonstrated experience with health authority submissions
  • Knowledge of regulatory requirements throughout clinical/drug development and lifecycle management
  • Experience in representing regulatory affairs on development project teams