Regulatory Affairs Senior Manager/Associate Director
Altimmune (NASDAQ: ALT) is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating treatment for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). For more information on Altimmune, please visit www.altimmune.com.
Job Description: This individual will be responsible for providing regulatory CMC support throughout the product lifecycle (e.g., regulatory strategies, submission timeline development, change control and preparing submission documents). This position reports to the Head of Regulatory Affairs.
- Creates high quality, compliant CMC regulatory documents in support of US FDA INDs and ex-US CTAs/IMPD
- Manages regulatory CMC activities as assigned, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals
- Manages the timelines and compilation of IND/CTA, BLA/NDA/MAA, Safety, and Lifecycle submissions and unscheduled safety reporting
- 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.
- Perform assessment of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation updates as needed
- Writes and performs technical review of all CMC documents in support of regulatory submissions; ensure all regulatory CMC documents (Module 2s and 3s) are prepared accurately and completed in a timely manner towards project completion
- Perform Technical review of certificates of analysis, specification, and stability protocol/report/data
- Attends relevant FDA meetings and interfaces with regulatory/competent authorities, negotiating resolution of CMC regulatory issues affecting Altimmune’s product development programs.
- Participates 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 nursing, science, engineering or health related field required with at least 5 + years regulatory experience in the biotech/pharma industry or advanced degree (MS, Ph.D., MD, PharmD) with at least 3 + years of regulatory experience.
- Experience in CMC regulatory lifecycle management, including compiling, reviewing, and managing CMC modules of eCTD submissions.
- Thorough knowledge of GxPs and ability to interpret FDA Regulations, EU Directives, and global regulatory guidelines governing clinical development, marketing submissions, and post-approval compliance for drugs and biological products.
- Excellent planning, organization, and project management skills including 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).
- Experience and knowledge with biologics (quality, regulatory, product development or manufacturing).
- Must be self-motivated with a positive attitude and ability to work well with others.
- Excellent oral and written communication skills.