Associate Director, Labeling & Packaging Control

Teva Pharmaceutical Industries Ltd. is a global pharmaceutical company specializing in the development, production and marketing of generic and proprietary branded pharmaceuticals as well as active pharmaceutical ingredients. Teva is among the top 20 pharmaceutical companies and is the largest generic pharmaceutical company in the world.

 

Position Description

Teva is looking for an Associate Director, Labeling & Packaging Control in our North Wales, PA location.  This position will be responsible for overseeing the activities of the labeling and packaging control function ensuring accurate, efficient workflow and compliance with FDA Regulations.

Responsibilities could include:

?  Ensure all labels for Teva USA are accurate and updated

?  Ensure all labeling documents meet deadlines for ANDA submissions and are in compliance with regulatory guidelines.

?  Ensure accuracy and compliance of documentation supporting the use of all packaging components marketed by Teva USA

?  Monitor, evaluate and implement FDA regulations and policies regarding labeling and packaging

?  Ensure continued compliance with SPL (structured product labeling) initiative

 

This position will be located in North Wales, PA. Some travel, less than 25% including international, may be required.

 

Qualifications

?  BS Degree in a scientific field, life-science program preferred

?  5-10 years of Generic Pharmaceutical Regulatory Affairs experience

?  3 years of management experience

?  Experience with FDA regulations for labeling required

?  Experience negotiating corporate positions directly with FDA

?  Proficient with computers (Adobe, MS Office and databases)

?  Excellent communication and presentation skills