Regulatory Affairs Director / Senior Director

Location
San Diego, CA
Posted
Dec 21, 2021
Required Education
Bachelors Degree
Position Type
Full time

Our client is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer. The company’s lead therapeutic, ADI-PEG 20, is a first-in-class biologic in late-stage clinical development. It has been tested in more than twenty clinical trials globally for a wide variety of cancers, including mesothelioma, sarcoma, melanoma, acute myeloid leukemia, and others. We are seeking an experienced, Regulatory Affairs Director to lead the BLA process for ADI-PEG 20. Applicants should have recent BLA submission experience in Biotech or Pharma and should be familiar with FDA regulations and policies. Familiarity with regulations and policies in other countries is a plus.

Job Description

  • Oversees industry specific regulations, policies and procedures, and ensures all government and company regulations are being met, both in the USA and in other countries where product specific development, including clinical trials, is occurring
  • Explains such regulations, policies and procedures to company personnel
  • Ensures compliance with these regulations
  • Advises others on regulatory and compliance matters
  • Evaluates applicable laws and regulations to determine potential impact on the company
  • Creates and implements regulatory strategies for planned BLA submissions
  • Provides technical review of data and reports
  • Leads regulatory activities related to biologics license application (BLA)
  • Coordinates regulatory documentation activities
  • Works closely with Clinical Affairs, Medical Affairs, and Manufacturing and Nonclincial colleagues to develop clinical/nonclinical, and CMC regulatory strategy
  • May supervise Regulatory Affairs team members

Education and Experience

  • Minimum requirement is a Bachelor’s Degree in science or healthcare. A PhD is preferred.
  • Successfully prepared and filed a BLA.
  • At least 10 years of Regulatory and/or Project Management experience.

Location

  • The successful candidate will already be in the San Diego area, or willing to relocate to San Diego. A portion of time may be spent telecommuting.