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Jr. Regulatory Affairs Associate in Cranbury Township, NJ at Synerfac

Date Posted: 12/8/2018

Job Snapshot

Job Description

Work directly for a Central New Jersey (Middlesex County) area Pharmaceutical Manufacturing Company.


Jr. Regulatory Affairs Associate:



DUTIES & ESSENTIAL JOB FUNCTIONS
•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.

Job Requirements

QUALIFICATIONS
•BS degree in a scientific discipline, preferably Chemistry, Biology or Pharmacy is mandatory.
•1 to 2 years’ experience in pharmaceutical regulatory affairs.
•Attention to detail / Analytical
•Excellent oral and written (English) communication skills.
•Knowledge of US drug regulatory requirements and eCTD (electronic common technical document) preferred.
•Integrity, focus, strategic planning/thinking, cooperation and positive attitude will all be extremely helpful.
•Excellent attendance


Mark Rice
Synerfac Technical Staffing
Phone: 732-271-933
Fax: 732-271-9110
mrice@synerfac.com