Teva Pharmaceuticals USA, Inc.

Regulatory Affairs Associate II US Generics Labeling

US-NJ-Parsippany
Requisition #
17-19995
# Positions
1
Experience (Years)
3
Category
Regulatory Affairs - Regulatory Affairs

Overview

Teva Pharmaceuticals, the leading Generic pharmaceutical manufacturer in the world,  is now seeking a Labeling Associate II to join its Generics Regulatory Affairs team.  The Regulatory Affairs Labeling Associate II is responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA). Labeling documents include those prepared for FDA PADERs and annual reports as well as submission labeling files for Abbreviated New Drug Applications (ANDAs), amendments and supplements to ANDA’s that are in compliance with regulatory requirements and within company timelines.  Candidate will be required to work independently and have proficiency in FDA labeling regulations and guidances to the level of applying them effectively to all work output.

Responsibilities

Prepare, file and maintain the labeling section of US Periodic Adverse Drug Experience Reports (PADERs) for approved applications.

 

Expert in building compliant and accurate labeling content by being proficient in the following:

  • Obtaining needed reference materials including CMC information and Reference Listed Drug (RLD) labeling and being able to effectively develop accurate label content from these resources.
  • Researching and carving out patent/s and/or exclusivity/s information based on filing strategy.

Experience in the establishment of Structured Product Labeling

 

Work within the team to proofread established labeling files for content accuracy either manually or by utilizing the electronic proofreading tool.

 

Assure all labeling and submission documents are prepared in accordance with established Teva standards and procedures and meet FDA requirements and guidelines.

 

Assist in the preparation of the labeling portion of Annual Reports (ARs) to comply with the Code of Federal Regulations (CFR) by providing  current in-use professional labeling as well as a summary of the revisions applied during the required reporting period.

 

Serves as a backup, when needed, in the monitoring of FDA websites for Reference Listed Drug (RLD) updates

 

Attend project meetings; track workload and implement labeling changes based on project responsibilities. Work with manufacturing/packaging sites concerning labeling changes and implementation, and respond to e-mail queries related to activities associated with assigned projects to ensure accurate daily workflow.

 

Qualifications

BA/BS or equivalent combination of education and experience. BA/BS in a scientific or regulatory area preferred

 

Minimum of 2 to 3 years pharmaceutical labeling experience.

 

Knowledge of FDA regulations and guidances related to generics labeling.  Scientific background or familiarity with medical terminology and knowledge of FDA regulations and guidance’s preferred

 

Possesses knowledge and thorough understanding of all FDA requirements pertaining to labeling.

 

Proficiency with electronic labeling files and SPL (Structured Product Labeling);

 

Proficient in standard PC computer programs such as Microsoft Office, Excel, Outlook, PowerPoint, Sharepoint, and Adobe Professional

 

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