Associate Director, Regulatory Affairs, BIOLOGICS

There are outstanding growth opportunities with this growing biologics company. They have products on the market and a solid pipeline with compounds at all stages of development.

 

Responsible for preparing, implementing, communicating, and coordinating regulatory projects, plans and schedules with scientific (clinical and preclinical), manufacturing, and business development project team members for biological products.  Responsible for collecting, preparing and assembling documentation required for Investigational New Drug Applications, and Biologic License Applications. 

 
 Lead innovative regulatory strategy development for all phases of drug development for biological investigational products
Monitors product related corporate activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices.
Represents Regulatory Affairs and provide guidance at project team meetings.
Submits regulatory information to FDA and world-wide regulatory agencies including, but not limited to,  INDs, BLAs, and manufacturing, preclinical and clinical protocols and amendments, and adverse experience reports. 
Must be action oriented, have customer focus and excellent time management and organizing skills

 

Requirements:

 

Education:  BS  in a scientific discipline; MS or Ph.D preferred

 

Experience:  Minimum of 5 years experience in Regulatory Affairs. Knowledge of FDA regulations required.  Regulatory experience in biological products required. Direct liaison experience with FDA required.  Knowledge of international regulatory guidelines, GCP and GMP requirements is desirable.