Our client is seeking an Associate Director/ Sr. Manager of Regulatory to join their growing regulatory team! Right now our client has two active IND's and 2 more pending. In 6-9 months they will have a total of 9 active IND applications. They are seeking a candidate who will oversee the daily activities and help with the amount of work load.
* Minimum education bachelor's degree in nursing, science, engineering or health related field required
* 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
* Vaccine experience
* 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
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.