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Associate Director, Regulatory Affairs Global Respiratory and Oncology - FRAZER, PA

Teva Pharmaceuticals


Location:
Frazer Requisition, PA
Date:
12/12/2017
2017-12-122018-01-10
Job Code:
17-20255
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Job Details

Careers - Teva Pharmaceuticals in the US -Associate Director, Regulatory Affairs Global Respiratory and Oncology - FRAZER, PA

Associate Director, Regulatory Affairs Global Respiratory and Oncology - FRAZER, PA

US-PA-Frazer
Requisition #
17-20255
# Positions
1
Experience (Years)
7
Category
Regulatory Affairs - Regulatory Affairs

Overview

The Associate Director/ Director, Regulatory Affairs is primarily responsible for developing global regulatory strategies, active participation on core project teams, review and comment of draft FDA submissions and internal documents, contacting the FDA as needed, and performing due diligences and NTE assessments on a as assigned basis.

Responsibilities

  1. Develop and continually evolve global regulatory strategies for Teva specialty products. Align global regulatory strategy with key product goals for development and life-cycle management.
  2. Communicate global regulatory strategies to core project team members and regulatory management.
  3. Attend and actively participate in core project team meetings to provide regulatory guidance to assist project team in achieving of key product goals for development and life-cycle management.
  4. Lead or participate in global regulatory team meetings.
  5. Attend project sub-team meetings as required
  6. Primary regulatory contact with US FDA for product specific applications.
  7. Comprehensively author and review regulatory documents to support submissions to FDA (meeting requests, initial INDs, original NDAs/BLAs, efficacy supplements, etc).
  8. Review incoming FDA correspondence, determine its distribution, and initiate a rapid response team meeting when needed.
  9. Perform due diligence and NTE assessments as assigned, or as business needs require
  10. Mentor Internal Medicine staff when needed. 

 

 

Qualifications

Education Required:   Minimum BS degree in scientific or healthcare discipline, equivalent combination of education and related experience.

 

Education Pred:  R.PH., Pharm.D, M.S., Ph.D., or equivalent

 

Experience Required: Minimum 7 years in specialty pharmaceutical regulatory affairs on a global basis with emphasis on nonclinical and clinical development. Advanced experience with FDA NDA/BLA submissions. Advanced knowledge of FDA regulations and guidance documents. Working knowledge of eCTD structure.

 

 

Specialized or Technical Knowledge                 RAC certification is beneficial, but not mandatory.

Licenses, Certifications needed:                      Biologics or Medical Device experience a plus.

 

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Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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