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Associate I, Regulatory Global Labeling - United States  

Biomarin (company)

Posted on : 24 June 2017

Project Description

  • Our company  is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. 
  • We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. 
  • These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. 
  • Our company  will continue to focus on advancing therapies that are the first or best of their kind.      
  • Our company’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. 
  • These engineers, technicians, scientists and support staff build and maintain company’s cutting-edge manufacturing processes and sites,  provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.  Come join our team and make a meaningful impact on patients’ lives.       

  • The Labeling Associate ensures the labeling documents for submission are compliant with regulations, and internal SOPs. 
  • The Labeling Associate will participate in the development, review, and submission of US and International labeling projects. 
  •  The Associate will edit and QC labeling components for submission and implementation, support labeling timelines from E2E. 
  • This position is responsible for maintaining the electronic labeling and physical labeling components’ repositories and tracking labeling milestones.

This position will be responsible for:
  • Provides regulatory labeling support including QC of labeling documents, artwork QC, translations management, and labeling project coordination. 
  • Perform quality checks in accordance with local labeling requirements (EU, US, and ROW).
  • Ensure regulatory compliance, accuracy, timely completion and version control of all new and revised text on labeling components.
  • Preparation, approval management, and distribution of product labels including drafting initial document to SPL approval.
  • Manage electronic and physical labeling repositories.
  • Perform continuous coordination, monitoring and expediting of labeling changes to meet established deadlines for submissions and implementation. Includes, maintaining and tracking project schedules, deliverables, timelines and activities and follow up with SMEs and project team members. 
  • Provide input to internal tracking systems/databases to control workflow and ensure labeling projects/submissions and implementation deadlines are met.
  • Assist with regulatory research supporting labeling activities.
  • Support Product Labeling Leads in the maintenance of labeling regulatory / quality systems, and updating and managing electronic labeling files.
  • Communicate with labeling managers to ensure any new regulatory requirements are incorporated into the labeling documents.
  • Provide input to internal tracking systems/databases to control workflow and ensure labeling projects/submissions and implementation deadlines are met.
  • Work with Packaging Operations and Supply Chain to facilitate implementation of labeling for printed packaging components.
  • Review worldwide labeling against the Core Company Safety Information and with regard to business needs for accuracy and consistency of message.
  • Work with cross-functional stakeholders to support timely submission, approval, and distribution of product labeling with the strategies and objectives developed by the labeling teams
  • Receive and collate labeling text from labeling team members and put text into appropriate labels
  • Prepares communications for approved/effective product labeling to key stakeholders.
  • Prepare drug listing and establishment registrations for the US.

Required Skills:
  • 0-3 years’ experience (2-5 years or a Masters for Associate II). Working knowledge of FDA and EU labeling regulations/guidance a plus.
  • Have a passion for quality and an impeccable detail orientation 
  • Strong planning and organizational / project / workload management skills
  • Thrive in, and be able to work in, a fast paced environment 
  • Technology savvy: extensive experience in PC-Based word processing software, databases and spreadsheets, including Microsoft Office Word and Excel, Adobe Acrobat and MS Project 
  • Familiarity with SPL, PLR, QRD templates and other formatting requirements
  • Solid interpersonal (verbal and written) communication skills at all levels (peers to executive management)

Desired Skills:
  • International labeling experience including Latin America, APAC Regions, and MENA CIS Regions desirable. 
  • Knowledge of medical terminology a plus.  

Minimum requirements a four-year degree, preferably in life sciences. 

Equal Opportunity:      
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.