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Job

Director of Regulatory Affairs

  • Location

    New Jersey

  • Sector:

    Life Sciences

  • Contact:

    Adele McKenna

  • Contact email:

    a.mckenna@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    13 days ago

  • Expiry date:

    2020-12-12

Hamlyn Williams has partnered with an exciting Pharmaceutical company, based in New Jersey, in their search for a Director of Regulatory Affairs. Our client seeks a candidate who will support a variety of regulatory projects, including developing and implementing global regulatory strategy and life cycle management of said projects.

This is an opportunity to be part of a very passionate team and to be a critical member on many projects. 

 

Responsibilities

  • Developing global product regulatory strategy to efficiently obtain approval by regulatory agencies for a variety of projects simultaneously 
  • Communication with the health authorities, including: calls and email, chair meetings,  prepare the internal team for meetings with FDA at any phase of drug development 
  • Leadership in preparation of regulatory filings for submissions including: IND applications, meeting requests, post-marketing commitments and annual reports  
  • Reviewing global marketing applications, clinical study reports, investigator brochures before release 
  • Conducting initial IND and Clinical Trial Applications (CTA) content review and approval 
  • Manageing regulatory project aspects including strategy, resources, costs, time and vendors

Qualifications

  • 5+ years of experience in pharmaceutical regulatory affairs experience 
  • Demonstrated experience with IND, NDA, GCP, ICH and other regulatory guidance requirements  
  • Ability to manage multiple responsibilities with a high degree independence 
  • Strong written communication skills   
  • MS or Doctoral degree in an applicable field of study 

 

Apply here or email a.mckenna@hamlynwilliams.com if you are interested in working with a leading organization in the industry.