Associate Director, Regulatory Affairs Strategy at The Judge Group Inc. in PARAMUS, New Jersey

Job Description:

Location: Paramus, NJ

Salary: $170,000.00 USD Annually - $175,000.00 USD Annually

Description: Our client is currently seeking a Associate Director, Regulatory Affairs Strategy



Essential Duties and Responsibilities




•Serves as a regulatory lead to FDA and provides strategic input with the regional regulatory leads responsible for ex-US regulatory activities. Provide oversight of regulatory consultants and vendors where applicable.




•Provides regulatory strategic support and guidance to project teams.




•Mentor and management of direct reports.




•Performs research on regulatory precedence and competitive intelligence as needed.




•Contributes to identification of potential issues/gaps and proposes creative risk mitigation strategies to address gaps affecting optimal and timely submissions and approvals.




•Assess and communicate regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines.




•Supports and manages regulatory CROs in the planning and execution of US and ex-US global health authority interactions including support of preparation and submission of meeting requests, briefing books, meeting preparations, Pediatric Investigational Plans (PIPs), Orphan Drug Designation applications, Fast Track and Breakthrough Designation requests, Rare Pediatric Disease Designations, etc., as applicable




•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.




•Interprets and communicates health authority correspondence effectively and quickly to senior leadership and project teams.




•Participates in project team meetings and provides updates on regulatory activities.

Qualifications & Requirements:

• 
  
  • BS/BA in Life Sciences in a relevant field required; advanced degree strongly preferred (PharmD, MD, PhD) with 7-10 years of regulatory experience in the branded biotech/pharma industry supporting regulatory strategy, submissions, drug promotion/advertising and US labeling.
  • Working knowledge of prescription drug laws, ICH and FDA guidelines, FDA regulations and other health authority guidelines.
  • Experience in rare disease/accelerated approvals preferred.
  
  
  • Regulatory Affairs Certified is a plus.
  
  
  
  

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Contact: anarayan@judge.com


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