Senior Manager, Regulatory Affairs Strategy
The Judge Group Inc.

Job Info

---

Location: Paramus, NJ
Salary: TBD
Description: Our client is currently seeking a Senior Manager, Regulatory Affairs Strategy

This job will have the following responsibilities:

• 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.
• 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.
• Provides regulatory strategic support and guidance to project teams.
• 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.

Qualifications & Requirements:

• 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.
  
• Experience in rare disease/accelerated approvals preferred.
  
• Regulatory Affairs Certified is a plus.
  

Contact: arawat@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

This job has expired.