Teva Pharmaceuticals USA, Inc.

Manager/ Sr. Manager, Regulatory Affairs Brand Labeling (Frazer, PA or Other Locations)

US-PA-Frazer | US-NJ-Parsippany | US-KS-Overland Park
Requisition #
17-19438
# Positions
1
Experience (Years)
3
Category
Regulatory Affairs - Regulatory Affairs

Overview

 

Successfully lead the development and maintenance of label content for marketed products within assigned therapeutic areas. Adhere to all procedures related to label content development, maintenance, and implementation and maintain these procedures to assure process integrity and effectiveness. Successfully execute labeling implementation strategies and assure compliance by all affected functions. Work with functions affected by labeling implementation to assure that content review/approval procedures are in place for all labeling documents. Candidate must be proficient in effectively leading teams to successful outcomes and must be proficient in all FDA labeling regulations and guidances. Candidate must be able to provide sound interpretation and successfully apply the FDA regulations and guidances to all work output.

 

This position can be based in one of our three locations:  Frazer, PA,  Parsippany, NJ or Overland Park, KS

Responsibilities

    •  Work with functions affected by labeling implementation to assure that labeling content is implemented in accordance with established regulatory and/or business timelines. (20%)
    •  Lead Working Group activities to assure successful label content development and maintenance for products within assigned area. Labeling includes prescribing and patient information as well as all forms of container labeling. (20%)
    • Facilitate the review/approval of labeling component artwork and/or proofs. Prepare and manage the procedures related to these activities to assure compliance with regulatory and quality standards. (20%)
    •  
    • Facilitate the preparation of labeling documents required for submission to the US FDA in support of new labeling content and/or revisions and assure the accuracy of these documents by assuring compliance with relevant procedures. (15%)
    •  
    • Prepare Company Core Data Sheets (CCDSs) for assigned products including preparation of initial content based on source data, manage internal review/approval procedures and assure that all relevant supporting documentation is available and archived. (10%)
    •  
    • Proactively monitor changing trends, regulations, and guidances impacting pharmaceutical labeling and be able to assess impact. (10%)
    • Prepare label updates required for routine reporting to FDA and other health authorities (e.g., Annual Reports, PSUR's). (5%)

#linkedin

 

Qualifications

Education:

  • Required: BA/BS
  • Preferred: BA/BS with a Scientific or Regulatory background
  •  

REQUIRED EXPERIENCE

  • Minimum 3 years pharmaceutical label content development experience.
  • Proficient in FDA labeling regulations and guidances; expert in applying to all labeling work output.
  • Proficient in FDA regulations pertaining to basic drug development with focus on those that impact labeling decisions and requirements.
  • Proficient in the fundamentals of Core Labeling and experience in preparation of these documents.
  • Supervisory experience highly preferred.SPECIALIZED OR TECHNICAL KNOWLEDGE LICENSES, CERTIFICATIONS NEEDED
  •  
  • Experience with databases and computer software such as Documentum, Sharepoint, Excel; Structured Product Labeling development.
  • Experience with proofreading software.FUNCTIONAL KNOWLEDGE
  •  
  • Proficiency in interpretation and application of FDA labeling regulations and guidances.
  • Understanding of drug development process and components of the regulatory function.
  • COMPANY/INDUSTRY-RELATED KNOWLEDGE
  • Pharmaceuticals
  • Regulatory Affairs
  • Labeling

JOB-SPECIFIC COMPETENCIES

  •  Ability to lead and manage teams to successful outcomes; demonstrated ability to maintain objectivity to successfully manage conflicts; excellent oral and written communication skills. Works cooperatively with others; can also manage tasks and priorities independently.
  • Viewed as a resource; will take the time to research available information to solve problems and provide solid regulatory guidance on labeling matters.
  • Strict attention to detail; able to detect errors, determine gaps in processes, and proactively mitigate them.
  • Demonstrates an openness to change and is flexible in managing changing priorities and demands.
  • Willingness to learn and help others; good colleague, team member, and business partner; customer-focused with a positive approach to all tasks.

#linkedin

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.