Suffolk is Educated

Regulatory Affairs Specialist

Overview

Our team is growing! We are adding a Regulatory Affairs Specialist to join our RA team.

This role will support the Regulatory division with guidance to write, critically review, evaluate, compile and publish FDA submissions (ANDAs, amendments, supplements, annual reports and additional documentation as needed).

Description

  • Regulatory review raw material during sourcing, obtain and review RA statements and relevant technical information to ensure compliance with US regulations and guidance
  • Collect filing required statements, commitments, LoAs and DMF from manufacturers/vendors
  • Prepare/review regulatory submission documents to be in compliance with FDA review standard, ensure all problems identified and addressed concurrently and assembled in accordance with established timelines
  • Initiate, create and proofread all OTC and Rx product labeling components from all locations, including but not limited to bottle labels, cartons, Package Insert, Medication Guide, Side-by-Side comparisons of labels/cartons, SPL, FPL for regulatory submission, as well as DailyMed Listing, etc.
  • Perform new, renewal and amendment of global registrations/licenses, including but not limited to US, China, Canada, EU, etc.
  • Implements policies to assure on-going compliance of Regulatory Affairs activities

Qualifications

  • Bachelors degree in Pharmaceutical Sciences and or Chemistry
  • Strong verbal and written communication skills
  • 3-5 years of Regulatory affairs experience in a pharmaceutical setting
  • Proficient in MS Office Suite
  • Working knowledge applicable regulations; US FDA, SOP and cGMP standards
  • Strong proofreading skills
  • Detail oriented, organized and self-motivated.
  • Ability to multi-task

Apply Now

Job Snapshot


Type:

Full Time

Posted:

3/24/17

Company Snapshot


Company:

A&Z Pharmaceutical, Inc.

Location:

Hauppauge, NY

Industry:

Manufacturing/Pharmaceutical

Established:

1995

Website:

azpharmaceutical.com/