Senior Manager, Regulatory Affairs Strategy

  • Paramus
  • The Judge Group Inc.
<b>Location: </b> Paramus, NJ<br> <b>Salary: </b> TBD<br> <b>Description: </b> Our client is currently seeking a Senior Manager, Regulatory Affairs Strategy <br> <br> <b>This job will have the following responsibilities:</b> <br> <ul> <li>Responsible for developing and implementing short and long term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their life cycle. </li> <li>The candidate will manage, and lead submission related activities associated with the US and ex-US fillings for assigned products, ensure timelines are appropriately managed and met, and issues are appropriately raised and resolved in a timely manner.</li> <li>Provides regulatory strategic support and guidance to project teams.</li> <li>Assists and/or leads in planning and execution of major and life-cycle management maintenance submissions and responses to regulatory authorities related to INDs, amendments, NDAs and supplements within company timelines and in accordance with regulations and guidelines.</li></ul> <br> <b>Qualifications & Requirements:</b> <br> <br> <ul> <li>BS/BA in Life Sciences in a relevant field required; advanced degree strongly preferred (PharmD, MD, PhD) with 5 or more years of related product regulatory experience in biotech/pharma branded industry including 3 or more years of new drug branded product strategy and submissions experience.<br></li> <li>Experience in rare disease/accelerated approvals preferred.<br></li> <li>Regulatory Affairs Certified is a plus.<br></li></ul> <br> <b>Contact:</b> arawat@judge.com<br> <br>This job and many more are available through The Judge Group. Find us on the web at www.judge.com<img src="https://counter.adcourier.com/YmJnZW5lcmljLjk0ODcwLjEyNTI0QGp1ZGdlY29tcC5hcGxpdHJhay5jb20.gif">