Regulatory Affairs (Lead)

US-NY-Bridgewater
Job ID
2017-7400
Category
Information Technology

Overview

Our Client is a global leader in IT services, digital and business solutions that partners with its clients to simplify, strengthen and transform their businesses. Our Client has been recognized by Brand Finance as one of the Big 4 Global IT Services Brands, is looking for a Regulatory Affair (Lead) for full time project in Bridgewater NJ, below is the detail requirement. 

 

"U.S. Citizens and those authorized to work in the U.S. are encouraged to apply. We are unable to sponsor at this time."

Responsibilities

  • Minimum 5 years experience in electronic submission publishing,  routine IND maintenance submissions.
  • Minimum 5yrs electronic submission publishing tools a must (eCTD, Insight and eCTD submission publishing.
  • Experience in regulatory affairs knowledge of drug development and drug lifecycle management.
  • You should have different submission procedures (US, Caribbean, South America & Canada).
  • Good understanding in clinical Practice (GCP) 21 CFR part 11.
  • Minimum 3-5Yrs experience in people management is added advantage

Qualifications

  • Bachelor's degree in Computer science or equivalent, with minimum 9 years of relevant experience.
  • Demonstrate excellent communication skills including the ability to effectively communicate with internal and external customers.
  • Ability to use strong industry knowledge to relate to customer needs and dissolve customer concerns and high level of focus and attention to detail.
  • Strong work ethic with good time management with ability to work with diverse teams and lead meetings.

  

Mageshwaran

Lorven Technologies, Inc.

101 Morgan Lane | Suite 209 | Plainsboro | NJ 08536

Tel : 609-799-4202 X 202 | Fax:609-799-4204

Email: mage@lorventech.com | Web: www.lorventech.com

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.