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Regulatory Affairs Associate - 18-38605
Ref No.: 18-38605
Location: East Windsor, New Jersey
Position Type:Direct Placement
Pay Rate : $ 19.00 - 23.00 /Hour
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:None
THIS IS A DIRECT HIRE OPPORTUNITY FOR A REGULATORY AFFAIRS ASSOCIATE
Duration:  Direct Placement
Client Location:  East Windsor, NJ
Work Schedule:  40 Hours Weekly
Pay Rate:  $19.00 - $23.00 Hourly
Benefits: ACA Compliant Medical Insurance

RESPONSIBILITIES
 
  • 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.
  • 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.
  • Perform other duties as assigned
EDUCATION & EXPERIENCE
  • 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.
  • Integrity, focus, strategi planning/thinking, cooperation and possitive attitude
To Apply for immediate consideration please send resume to Louis Moliterno at Louis.Moliterno@onboardusa.com and reference job # 18-38605 in the Subject Line and indicate the best times to contact you (please include nights and weekends if needed).
 
**Candidates must complete background and drug screenings before starting any assignment.
 
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.
 
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.