CMC Director/Senior Director, Regulatory Affairs

Altimmune•Gaithersburg, MD

About The Position

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.

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.

Responsibilities

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.