Altimmune (NASDAQ: ALT) is a clinical stage biopharmaceutical company focused on developing treatments for obesity and liver diseases. Our pipeline includes next generation peptide therapeutics for treatment of obesity, metabolic dysfunction-associated steatohepatitis (MASH), alcohol-associated liver disease (ALD), and alcohol use disorder (AUD). For more information, please visit www.altimmune.com.Job Description: This individual will be responsible for providing global regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, preparing CMC filings and submissions to regulatory applications, regulatory submission timeline development, and regulatory intelligence). This position reports to the Head of Regulatory Affairs.Essential Functions:Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial applicationsManages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goalsResponsible 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 and assists in the development of relevant timelines and ensures execution to meet corporate goalsPerforms regulatory assessments of CMC changes, identifying global regulatory filing requirementsResponsible 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 agenciesLeads CMC-related FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune's development programsInterprets FDA regulations/guidelines governing drugs, devices, and biologics and advises Senior Management on pertinent regulatory intelligenceRepresents and participates in project/program teams and sub-teams, as requiredParticipates in the development, review, and implementation of departmental SOPs and processes.Job Requirements (Essential knowledge, skills and attributes):S/Ph.D. degree in chemistry, pharmaceutical science, engineering or related discipline is preferred with a minimum of 5-10 years regulatory CMC or CMC-related experience in the biotech/pharma industryExperience in CMC regulatory lifecycle management, including compiling, reviewing, and managing CMC modules of eCTD submissionsOperational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agenciesAbility to interpret FDA Regulations, EU Directives, and global regulatory guidelines governing CMC filing requirements for approval of marketing and clinical trial applications for drugs and biological productsExcellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneouslyExperience 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 othersExcellent oral and written communication skills. Altimmune provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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