Workplace Designation:Depending upon location, this role will be hybrid or remote and will require some travel as business needs dictate.
Summary of Position:
This individual will be responsible for providing strategic regulatory advice and oversight for all of Altimmune's US regulatory applications, including the preparation and management of relevant clinical, nonclinical, advertising, promotional, and labeling aspects of relevant US regulatory submissions, responses, and correspondence. This role will act as the main point of contact and liaison with the US FDA. This position reports to the Vice President, Regulatory Affairs.
Essential Functions:- High-level management of regulatory projects as assigned, assistance in the development of regulatory submission timelines, and ensuring execution to meet corporate goals
- Oversee the timelines, review, and compilation of IND, BLA, NDA, promotional, and lifecycle submissions, including any safety reporting, as required
- Manages the preparation and submission of formal regulatory meeting requests and briefing packages and coordinates the face-to-face or online meetings with regulatory agencies
- Plays a key role in the development of regulatory strategy and writing of regulatory submissions
- Interprets FDA regulations/guidelines governing drugs, devices, and biologics and advises Senior Management on pertinent regulatory intelligence
- Attends relevant FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of regulatory issues affecting Altimmune's product development programs
- Plays a leading role in the development, review, and implementation of departmental SOPs and processes
- Other duties as assigned.
Job Requirements (essential knowledge, skills, and attributes):- Minimum education Bachelor's degree in science, engineering, or a health-related field required with at least 6 years of regulatory experience in the biotech/pharma industry, or a Ph.D., MD, PharmD with at least 6 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 FDA regulations and global regulatory guidelines governing clinical development, clinical trial applications, marketing, and post-approval application submissions. Prior experience reviewing and submitting advertising and promotional materials for drugs and biological products is preferred
- Excellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneously
- Must be self-motivated with a positive attitude and the ability to work well with others
- Excellent oral and written communication skills.
