Director, CMC Regulatory Affairs

Essential Functions

• Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial applications
• Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals
• Responsible for the preparation of all CMC sections/information filed in support of global clinical trial and marketing applications; ensures all CMC regulatory filings are prepared accurately and completed in a timely manner
• Manages global CMC regulatory projects as assigned, assists in the development of relevant timelines, and ensures execution to meet corporate goals
• Performs regulatory assessments of CMC changes, identifying global regulatory filing requirements
• Responsible for submission of supporting amendments and updates to relevant applications for CMC-related changes
• Manages the preparation and submission of formal CMC-related regulatory meeting requests and briefing packages, and coordinates meetings with regulatory agencies
• Led CMC-related FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune’s development programs
• Interprets FDA regulations/guidelines governing drugs, devices, and biologics and advises Senior Management on pertinent regulatory intelligence
• Represents and participates in project/program teams and sub-teams, as required
• Participates in the development, review, and implementation of departmental SOPs and processes

Job Requirements (Essential knowledge, skills, and attributes)

• M.S/Ph.D. degree in chemistry, pharmaceutical science, engineering, or a related discipline is preferred, with a minimum of 5-10 years of regulatory CMC or CMC-related experience in the biotech/pharma industry
• Operational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agencies
• Experience and knowledge in the preparation of global regulatory submissions (e.g., original IND/IND amendments, CTAs)
• Excellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneously
• Excellent oral and written communication skills