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Regulatory Affairs Director

Jobot

This is a Full-time position in New York, NY posted April 30, 2021.

Fully Remote Regulatory Affairs Director for a premiere global biopharmaceutical company

This Jobot Job is hosted by: Darwin Porras
Are you a fit? Easy Apply now by clicking the “Apply on company site” button and sending us your resume.

A bit about us:

Global biopharmaceutical company focused on oncology clinical trial stage operations. Headquartered in New York but looking for a fully remote RA Director.

Why join us?

We look for individuals who can join our organization and contribute to our vision, values and overall company culture.

We provide all of our employees with an exceptional compensation package including:
Competitive Base Salary
PTO
Holiday Pay
Health, Dental and Vision Insurance
401k matching

Job Details

  • Minimum education Bachelor’s degree in nursing, science, engineering or health related field required with at least 5 + years regulatory experience in the biotech/pharma industry or advanced degree (MS, Ph.D., MD, PharmD) with at least 3 + years of regulatory experience.
  • Operational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agencies.
  • Thorough knowledge of GxPs and ability to interpret FDA Regulations, EU Directives, and global regulatory guidelines governing clinical development, marketing submissions, and post-approval compliance for drugs and biological products.

Interested in hearing more? Easy Apply now by clicking the “Apply on company site” button.