A bit about us:
Based in Gaithersburg, MD we are a clinical stage biopharmaceutical company focused on developing liver disease and immune modulating therapies. Our diverse pipeline includes next generation peptide therapeutics, chronic Hepatitis B, and immunostimulants for the treatment of cancer and intra-nasal vaccines. 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!
- 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