Director, Regulatory Affairs

🔥 3 hours ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

⏰ Full Time

🔴 Lead

🚔 Compliance

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Altimmune, Inc.

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 1997

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Altimmune is a late-stage clinical biopharmaceutical company focused on developing therapies for serious liver diseases. The company’s pipeline targets conditions with high unmet need including metabolic dysfunction-associated steatohepatitis (MASH), alcohol use disorder (AUD), and alcohol-associated liver disease (ALD). Its lead candidate, pemvidutide, is an investigational therapy designed to address liver disease via glucagon receptor activity and metabolic effects through GLP-1 activity. Altimmune advances treatments by addressing fundamental mechanisms driving liver disease progression.

📋 Description

• 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 and 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 • Leads 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.

🎯 Requirements

• 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 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 • Ability 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 products • Excellent planning, organization, and project management skills, including the 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.