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Title : NVG- Regulatory Coordinator -696
State : New Jersey   Date : Jun 19, 2019
Experience Level :  
Position Type : Regulatory Coordinator      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: East Hanover, NJ


Job Title: Regulatory Coordinator


Duration:  7+ months (extendable) contract on W2


Duties:
The Regulatory Coordinator is responsible for providing operational regulatory and compliance support on development projects/major line extensions through development, registration, and approval including post approval commitments. 

Major Accountabilities : 
Manage and prepare Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment , and New Investigator Submissions to ensure timely submissions in accordance with the FDA regulations 
Contribute to Module #1 documents including FDA forms and cover letters for maintenance submissions with management oversight 
Conduct monthly reconciliation to ensure timely submissions are in accordance with FDA regulations as well as meeting all client requirements for submission-related activities • Support US regulatory compliance activities, including timely review and updates to product specific information as provided by program team representative into a compliance database (DRAGON), when applicable 
Manage the user fee registration requests 
Manage and execute drug shipment ticket review process (US) 
In addition to regulatory manager, provide guidance to clinical functions on regulatory compliance activities, such as requirements for TOOs, VDRs, drug shipment etc. 
Assist regulatory managers to support compilation and release of submissions to regulatory agencies as well as submission-related activities for regulatory responses to health authorities


Skills:
Minimum of 2 years pharmaceutical experience desired 
Prior publishing/Regulatory Operations experience desired. 
Good communication and negotiation skills. 
Proactive personality. 
Fast and flexible, focused on timely delivery and stretch targets 
Ability to plan and prioritize workload 
Ability to work in a matrixed environment. 
Ability to build effective relationships across teams/projects.


Education:
Bachelors degree preferred



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
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