A bit about us:

Based in Gaithersburg, MD we are a clinical stage biopharmaceutical company focused on developing liver disease and immune modulating therapies. We are looking for a Regulatory Affairs Director (Biotech) to join our growing team!

Why join us?

  • Competitive Salary!
  • Great Benefits Package!
  • The Opportunity to Join an Amazing Team!

Job Details

  • 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.
  • Excellent planning, organization, and project management skills including ability to adjust to rapidly changing priorities and manage multiple projects simultaneously
  • Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs)
  • Must be self-motivated with a positive attitude and ability to work well with others
  • Excellent oral and written communication skills