Remote Senior Director of Regulatory Affairs, CMC

Remote Senior Director, Regulatory Affairs, CMC - 5+ Years Industry Experience

  • Gaithersburg, MD
  • $190,000 - $280,000
Easy Apply Now

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 looking for a Remote Senior Director of Regulatory Affairs, CMC to join our growing team!

Why join us?

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

Job Details

  • M.S/Ph.D. degree in a biomedical related field is preferred with a minimum of 5-10 years regulatory experience in the biotech/pharma industry
  • Experience in CMC regulatory lifecycle management, including compiling, reviewing, and managing CMC modules of eCTD submissions
  • Operational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agencies
  • Demonstrated 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)
Easy Apply Now
Easy Apply Now
Job Details
Managed by Jobot Pro
Job Type
$190,000 - $280,000