Senior Regulatory Labeling Specialist

Employer
PRA Health Sciences
Location
United Kingdom
Salary
£40,000- £55,000
Closing date
24 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
You need to sign in or create an account to save a job.

What you will be doing:

 

Labeling Operations

 

Supporting the global labeling lead teams on the development and submission of labeling components for regulatory agency approval. Controls the consistency of labeling through review of content across the product family.

Creates/manages FDA-required Structured Product Labeling (SPL) documents, e.g., Labeling, Bulk Drug Listing, Establishment Registration, Blanket No Change Certifications.

Creates and provides lifecycle management for Prescribing Information, Patient Labeling or packaging artwork (layout, mock-ups, production artwork). Provides regulatory review and acts as text approver through alignment between approved content and artwork.

Coordinates US labeling submission, approval and implementation activities through internal or client, systems and processes.

Provides operational support through the management of change control of labeling documents, creation and maintenance of annual report labeling summary with Fine Printed Labeling (FPL), maintenance of current competitor lists and monitoring for updates impacting labeling, and support of labeling implementation tracking.

Tracks compliance with established processes. Provides compliance data to department management, internal and external clients.

 

 

Core Responsibilities:

 

 

Global Labeling Tracker

 

Update Global Labeling Tracker upon receiving communications from relevant project leads

Follow up on status of labeling project, and update the tracker accordingly

Labeling Component Repository Tracker

 

Manage and Update the Tracker upon receiving new information regarding implementation and labeling samples

Labeling Implementation and Planning Meeting (LIP) tracker

 

Provide inputs to the LIP tracker in coordination with the GLL

Preparing and Entering Labeling Requirements for Artwork Creation (in AMS)

 

Identifying labeling requirements for artwork creation, liaising with the local regulatory or commercial contact.

The associate assigned for each individual Labeling Project is responsible for creating and managing Artwork Request Folder

The responsible associate should shortcut the original agency-approved labeling documents, complete an Artwork Request Form, and upload other necessary documentation for Pack Ops

The responsible associate should also ensure timely communications with Pack Ops with any updates or revisions made on the labeling documents

Structured Product Labeling

 

Generate, publish and submit SPL

QC labeling documents

 

 

QC of labeling documents in AMS

 

QC labeling documents on Trackwise by utilizing DocuProof, DocuSign, Document Compare, and other relevant tools to ensure the highest quality of labeling documents and the artwork.

Remain in timely and accurate communications with the Labeling Project Lead and CMO regarding issues and discrepancies found during QC.

 

 

Preparing labeling documents for submission and response to Agency questions

 

Develop structure for labeling response, and prepare draft responses where applicable to labeling questions.

QC labeling documentation prior to submission

Document approvals from Sr Management

Identifying supporting information/annotations for labeling

 

 

What you need to have:

 

Regulatory Labeling Specialist 1

 

Bachelor’s degree in relevant field of study or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.

Minimum 1 year of relevant experience

Working knowledge of the scientific principles of the drug development process

Working knowledge of regulations pertaining to drug product labeling

Excellent oral and written communication skills Basic project management skills

Excellent attention to detail

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

The story of PRA Health Sciences would naturally talk about how we’ve become one of the world’s largest CROs. It would talk about our innovation and growth and would speak to our operational efficiencies and transparency. It would highlight our expertise and customization. And it would touch on the incredible differences we’ve made, over our more than 30 years, in helping to bring to market everything from niche treatments and therapies to blockbuster drugs.

More than anything else, our story would be about people. Not only our over 16,000 + employees operating in more than 80 countries, though they’d certainly be a big part of it, but also the people that inspire them. The heroes of any PRA Health Sciences story are the clients we serve and the people whose lives we help improve, all over the world. And our story has only just begun.

Contact Us
  • 500 South Oak Way
  • Green Park
  • Reading
  • RG2 6AD
  • GB
  • +44 (118) 918 1000
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert