Posted to MedZilla on 4/18/2019

Phaidon International

US-NJ, Global Head of Regulatory Affairs 452431245278-MZ


 
 

Global Regulatory Affairs Executive Director - Head

New Jersey 

$350,000 - $500,000 + bonus + excellent benefits + relocation



One of the world’s largest biopharmaceutical and medical device companies is looking to add to its already growing domestic presence. The successful candidate will be tasked with leading an award winning team that is currently the global leader in development, discovery, commercialization, and regulatory strategy of advanced therapeutics across a range of ailments. As an executive member of the regulatory staff, you will lead a growing team known for their exceptionally high standards when ensuring patient safety and adherence to FDA Regulatory Standards. 

 

This role is going to be one of the key regulatory hires in 2015 as the successful candidate will bring their strong technical and scientific background to help educate and develop the group in the following areas: strategy development, risk assessment and management; monitoring and communicating change in the regulatory environment. 

 

The ideal candidate should have a proven track record of success working in a matrix environment and experience negotiating regulatory strategies for a variety products with Health Authorities in US and Globally.

 


Key Responsibilities Include:     

  • Responsible for the contribution and implementation of regulatory strategy to support assigned products depending on candidate’s scientific background.
  • Act as a liaison between Health Authorities and internal team
  • Develop new Regulatory Strategy and Tactical plans as well as implement pre-existing plans.
  • Act as a project manager for new and pre-existing projects
  • Effectively negotiate regulatory agreements with Health Authorities
 


The successful candidate will have:

  • Advanced degree (PhD or PharmD) preferred  
  • 7-10 years experience in a pharmaceutical industry
  • 7-10 years of experience in US regulatory affairs preferred with at least 4-5 years in experience in Neurology.
  • Experience in Regulatory Strategy, hands-on FDA

Please visit our website at www.phaidoninternational.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.