Summary of Position
This individual will be responsible for managing operational aspects of regulatory submissions and correspondence with regulatory agencies, including document preparation and archiving. The position will report to Head of Regulatory and Quality.
- Manages regulatory projects as assigned and 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 .
- Assists 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 .
- 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 minimum education Ph.D., MD, PharmD with at least 3 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 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.
- Must be self-motivated with a positive attitude and ability to work well with others.
- Excellent oral and written communication skills.
Altimmune is an equal opportunity employer that values diversity
Email your cover letter and resume or CV to:
Please reference Position Req#17-103
Posted on July 27, 2017