Regulatory Affairs Associate


Job ID 18-00250

Industry Pharma

Job Type Permanent

Location East Windsory, NJ

Description

ESSENTIAL JOB FUNCTIONS

% OF TIME FREQUENCY ESSENTIAL DUTIES
80% Daily Regulatory support of new and existing products including the preparation of ANDAs, supplements, Annual Reports, and responses to FDA deficiency letters/information requests. Independently manage preparation (in paper or electronic formats (eCTD)), submission and monitoring progress of FDA review of ANDA's. Communication with functional groups for coordination and preparation of data for submission to FDA.
20% Daily Review change controls for regulatory requirements and according to appropriate regulations and guidance's.Familiar with Regulatory regulations (e.g. FDA guidance, ICH, 21 CFR etc). Review labels as per FDA guidance.



Qualifications

QUALIFICATIONS PREFERRED & REQUIRED
BS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy is mandatory. 0-2 years experience in pharmaceutical regulatory affairs. Attention to detail. Excellent oral and written communication skills. Knowledge of US drug regulatory requirements and eCTD preferred
 

LEADERSHIP SKILLS & ABILITIES
Integrity, focus, strategi planning/thinking, cooperation and possitive attitude