Regulatory Job Associate Director

Jobs Index - Index of recent job listings.

Resumes Index - Index of recently posted resumes.

RegulatoryCareers.com - Register here for more Regulatory Affairs Services Jobs

< Back

Next >

Associate Director MD Open (J#38724)

Title: Associate Director
Company: MedImmune
Status: Full Time, Employee
Job Category: Biotech/R&D/Science
Location: Gaithersburg, MD 20878

Location: MD Gaithersburg - Corporate Headquarters
Req: 02635

Major Duties and Responsibilities (including supervising others):
This is a leadership position responsible for preparing implementing communicating and coordinating regulatory projects plans and schedules with scientific (clinical and nonclinical) and business development project team members for assigned biological products. Responsible for evaluating documentation required to initiate and maintain Investigational New Drug Applications and Biologic License Applications.
1. Lead development of innovative regulatory strategy for all phases of drug development for biological investigational products.
2. Evaluating regulations establishing framework designing and implementing science based registration strategies for assigned compounds to ensure rapid high quality submissions consistent with the Target Product Profile (TPP).
3. Monitor product related corporate activities for regulatory compliance including all nonclinical and clinical plans and practices.
4. Represent Regulatory Affairs at project meetings and other governance related meetings providing guidance to Research Clinical Development and Manufacturing at Product Development Team meetings.
More...

RegulatoryCareers.com - Register here for more Regulatory Affairs Services Jobs

RegulatoryCareers.com is the premier job search website focused specifically on the employment needs of Regulatory Affairs Companies and Professionals. Use this as an exclusive resource to find your next job or employee. We guarantee that you will be pleased with the special focus of this web site.