Regulatory Labeling Specialist- Labeling- Strategy-CCDS-Remote

New Jersey  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

I have a 6 months contract requirement for a Senior Regulatory Labelling Specialist to join a market leading pharmaceutical organization. The role can be remote based and pays an attractive rate. The successful candidate will provide regulatory guidance and oversight of global labelling activities and serve as the lead on Company Core Data Sheets and labelling teams, providing strategic on the development and approval of all product, US prescribing information, and EU summary of product characteristics for assigned products.

Day to Day task required to undertake:
o Manage approval processes for assigned products, including management of deviations
* Partner with Global Drug Safety in the development and maintenance of Development Core Safety Information (DCSI) for assigned products.
o Manage DCSI approval process for assigned products
* Lead the development and maintenance of US prescribing information and EU Summary of Product Characteristics.
o Contribute to the development of labeling strategy, including contingency strategy for negotiation with regulatory authorities.
* Provide global, US, and EU regulatory labeling expertise to teams
* Represent Global Labeling on Regulatory sub-teams
* Train Regulatory Affairs staff

Key Requirements:

* Advanced/ Bachelor's degree in pharmacy or other scientific discipline

* 3-5years experience in Regulatory Affairs within Pharma* Thorough understanding of US and EU labelling regulations

If you are interested, please attach an up to date CV and I will be in touch.

To find out more about Real please visit www.realstaffing.com
Start date
01/2014
Duration
6 months
From
Real Staffing
Published at
21.12.2013
Project ID:
643629
Contract type
Freelance
To apply to this project you must log in.
Register